It has come to our attention that in certain scenarios described below, there is a remote possibility that the Omnipod DASH™ PDM (Personal Diabetes Manager) may suggest an insulin bolus amount based on incorrect information. Yes. If you would like to sync data from other diabetes devices or to your Android device. Ascensia, the Ascensia Diabetes Care Logo, and Contour are the trademarks and/or registered trademarks of Ascensia Diabetes Care. The next time the user enters the Bolus Calculator, they are presented a screen (Figure 4) which can suggest an inaccurate bolus amount. We are providing you with an update to the Medical Device Correction issued on Feb. 13, 2020 regarding replacements for the Omnipod DASH™ Personal Diabetes Manager (PDM). You can also visit our website, www.omnipod.com for updated information on the PDM replacement timing. The Bolus Calculator factors in the grams of carbohydrates entered, the user’s current blood glucose (BG) value, and the user’s insulin on board (IOB) to suggest a bolus amount. 4.1 out of 5 stars 28. Get it as soon as Mon, Jan 11. The use of third party trademarks does not constitute an endorsement or imply a relationship or other affiliation. For your patients using the Omnipod DASH™ System, please advise them: It is safe to continue using their Omnipod DASH™ PDM provided users are aware of the following simple steps to prevent this potential situation: If my patient(s) believes they’ve experienced the situations described: If they have any questions, please instruct them to contact our local Customer Care team (country-specific details above) at any time 24/7. Insulet's Omnipod system includes a wearable pod that delivers insulin doses and a controller that looks like a smartphone, called the Omnipod DASH … for updated information on PDM replacement timing. How should I communicate this information to my patients? The Bolus Calculator factors in the grams of carbohydrates entered, the user’s current blood glucose (BG) value, and the user’s insulin on board (IOB) to suggest a bolus amount. Premium print quality brings each design to life. This is a voluntary action and it may take several weeks to ship the replacement PDMs. $17.50 $ 17. The Omnipod DASH System, which received FDA clearance in June 2018, is the only DTSec and ISO 27001 certified insulin pump for cyber and information security and safety. A software update will be made to the next version of Omnipod DASH™ PDM which will provide a solution for this issue and is expected to be available in March 2020. Does this change the continued distribution of the Omnipod DASH™ System? This will replace the old BG value and ensure an accurate dose is calculated based on the current BG. It is safe to continue using the Omnipod DASH™ PDM provided users are aware of, and follow the steps detailed below to ensure incorrect information is not used to calculate the suggested amount of insulin to deliver: Has the Omnipod DASH™ PDM caused any serious injuries? Insulet is currently aware of 11 complaints associated with this issue and there have been no reports of injury. In the Omnipod DASH™ PDM, the Bolus Calculator feature can be used to calculate a meal and/or correction bolus. About Insulet Corporation: If the BG value is older than 10 minutes when the user tries to initiate a bolus, the Omnipod DASH™ PDM should prevent this bolus from being delivered (see Figure 1 below). Insulet said it has no reports of injuries at this time. Is it safe for users to continue using the Omnipod DASH™ PDM? NOTE: You can also access your Profile by clicking the Profile link beside your name on the Summary screen. The Omnipod DASH™ System will continue to be available in the United States, United Kingdom, Netherlands, and Italy. What is the expected experience with the Omnipod DASH™ PDM Bolus Calculator? Select Settings. ‎Omnipod DISPLAY™ is an application that displays your Omnipod DASH™ System information directly on your iOS smartphone. COVID-19: view a video response from our CEO, Omnipod DASH® System Resources and Troubleshooting, Omnipod® System Resources and Troubleshooting, Once activated, this new feature will automatically upload the PDM’s data to a user’s Glooko, For more information on how to enable Automatic Upload, For further assistance in setting up your PodderCentral account, please. Omnipod PDM data can also be uploaded and viewed in Tidepool's data management system. If you have any questions regarding the information provided in this Medical Device Correction, please contact 1-800-581-6359. We are voluntarily providing a replacement PDM to all Omnipod DASH™ users and. Sync your Omnipod DASH ® Personal Diabetes Manager (PDM), and compatible blood glucose meter (BGM), continuous glucose monitor (CGM) and exercise tracker to see all of your data in one place. Best seller at Pump Peelz - Constructed of durable yet eco-friendly vinyl that won’t leave a residue on your device. If the user is not aware of this issue and delivers the bolus, it may result in over- or under-delivery of insulin, which may lead to hypoglycemia or hyperglycemia. Go to my.glooko.com in your web browser and sign into your Glooko account. In the meantime, you may continue using your current Omnipod DASH™ PDM provided you follow the steps detailed above to ensure incorrect information is not used to calculate the suggested amount of insulin to deliver. In the meantime, you may continue using your current Omnipod DASH™ PDM provided you follow the steps detailed above to ensure incorrect information is not used to calculate the suggested amount of insulin to deliver. Glooko is the diabetes management platform that makes diabetes management easier! The cleared indication for the Omnipod DASH System states that the pump is able to reliably and securely communicate with compatible, digitally … Identify patterns and determine which day and time of day you are in the best control. Omnipod“ Dash Gel Skin- Soft Silicone Cover Designed to Protect The Omnipod Dash Device (Pink/Purple/Turquoise Tie-Dye) 4.8 out of 5 stars 158. How do you prevent the user from giving an inaccurate bolus? A software update is being developed to provide a solution for this issue and is expected to be available in the starting March 2020. Use the USB-A to USB mini-B cable to download insulin pump data from your PDM to your computer. The Acton, Mass.–based company is sending emails and letters to all affected Omnipod Dash users to warn them about the software bug — with replacement PDMs becoming available next month. Senior Vice President, Regulatory Affairs & Compliance. The Omnipod DASH ™ System is intended to streamline practice workflow for prescribers and make diabetes an even smaller part of life for patients and their caregivers. Always check the “Calculations” before initiating the bolus. If the user delivers the bolus, this may result in over or under delivery of insulin which may lead to hypoglycemia or hyperglycemia. A user enters a BG value into the Bolus Calculator and does not deliver a bolus (Figure 2). This email will include shipment tracking details and important user resources (Settings Transfer Guide and Settings Transfer Video). The Total Bolus is calculated based on the old BG value, even though no BG is displayed on the screen. A CGM sensor sends information about your glucose through a “controller,” which is a process or set of instructions using advanced math to solve a task. In Scenario 1, selecting “Yes” or “No” when prompted to confirm the cancelled bolus will prevent this situation. Peelz are a coated vinyl adhesive designed to fit over the OmniPod® DASH. • Use the 'Find… 50 ($17.50/Count) Save more with Subscribe & Save. We will provide new PDMs containing the software update to all Omnipod DASH™ users and we will contact them directly when we are ready to ship. This potential situation does NOT affect the Omnipod DASH™ Pods or the widely distributed Omnipod® Insulin Management System. Why are we issuing a Medical Device Correction? FREE Shipping on orders over $25 shipped by Amazon. On June 25th, we began shipping replacement PDMs to current users of the Omnipod DASH™ System within the United States. Glooko is a trademark of Glooko, Inc. and used with permission. Insulet just launched the Omnipod Dash about nine months ago in the U.S. and two months ago in Europe, but the company spent much of its J.P. Morgan Healthcare presentation focused not on the recent launch, but on the next-gen product that’s expected to come out during the second half of 2020. Enter your PIN Code to unlock your DASH. If the BG value is older than 10 minutes when the user tries to initiate a bolus, the Omnipod DASH™ PDM should prevent this bolus from being delivered (see. The Bolus Calculator factors in the grams of carbohydrates entered, the user’s current blood glucose (BG) value, and the user’s insulin on board (IOB) to suggest a bolus amount. Actual values will vary based on user input. FREE Shipping on orders over $25 shipped by Amazon. In the meantime, you may continue using your current Omnipod DASH™ PDM provided you follow the steps detailed above to ensure incorrect information is not used to calculate the suggested amount of insulin to deliver. This action and communication are being taken voluntarily and with the knowledge of the appropriate local health authorities. A software update will be made to the next version of Omnipod DASH. Download the free Glooko mobile app onto your iOS or Android smartphone or tablet, and create an account to get started. Users of the Omnipod DASH™ System may continue using their Omnipod DASH™ PDM. Additionally, this potential situation does NOT affect the Omnipod DASH™ Pods or the widely distributed Omnipod® Insulin Management System. Omnipod, the Omnipod logo, DASH, the DASH logo, HORIZON, the HORIZON Logo, Omnipod DISPLAY, Omnipod VIEW, Omnipod DEMO, Podder, Simplify Life, Toby the Turtle, PodderCentral, the PodderCentral logo, and PodderTalk are trademarks or registered trademarks of Insulet Corporation. What do I do if I am currently using the Omnipod DASH™ System? For this reason, this notice has been issued to help users identify and avoid the issue. Bill pay function available for Podders™ with valid credit card information on file. Plug one end of your USB-A to Micro cable into your computer and the other end of your cable into your DASH PDM. A software update is being developed to provide a solution for this issue, which is expected to be available starting March 2020. Omnipod DASH™ simplifies living with diabetes! My review of the *NEW* Omnipod DASH Insulin Pump system after wearing it for 3 days! Tap Export on the DASH PDM to export your data. Always enter the current BG into the Bolus Calculator before giving a bolus. doesn’t allow for other apps or cellular phone use. Omnipod DASH® System Quick Glance Guides are designed for HCPs and Podders™ to provide step-by-step instructions on key insulin delivery actions as well as basal and bolus settings adjustments. A software update is being developed to provide a solution for this issue and is expected to be available starting in March 2020. $17.50 $ 17. We will contact you when we are ready to ship your PDM. Users should be aware of the following simple steps to prevent this potential situation: If you have any questions, the following resources are available: What are you doing to ensure the performance of the Omnipod DASH™ PDM going forward? Scroll down to the Apps & Devices section, and click Upload Omnipod® PDM. ©2018-2020 Insulet Corporation. 50 ($17.50/Count) Save more with Subscribe & Save. Everything you need, on the go! This notice affects the Omnipod DASH™ PDM (using software version 1.0.50 and earlier). Always follow instructions on the Omnipod DASH™ PDM screen. Omnipod“ Dash Gel Skin- Soft Silicone Cover Designed to Protect The Omnipod Dash Device (Pink/Purple/Turquoise Tie-Dye) 4.8 out of 5 stars 160. Get it as soon as Mon, Jan 11. Download Toby’s … “Automated insulin dosing” is the term for an advanced sensor-enabled insulin pump system with three key parts. Yes. ©2018-2020 Insulet Corporation. As the manufacturer of the Omnipod DASH™ System, customer safety is Insulet Corporation’s top priority. We make almost $100,000 yearly and still get assistance with this. As part of our ongoing quality monitoring processes, we have identified that on rare occasions, the Omnipod DASH™ PDM may suggest an inaccurate bolus amount based on a blood glucose value that is more than 10 minutes old when the user does not exit the bolus calculator as designed or when a system alarm interrupts a bolus calculation. $17.50 $ 17. We have 1 OmniPod DASH System manual available for free PDF download: Quick Start Manual . To upload your Omnipod® data. Sync your Omnipod DASH® Personal Diabetes Manager (PDM), and compatible blood glucose meter (BGM), continuous glucose monitor (CGM) and exercise tracker to see all of your data in one place. Always enter a current BG into the Bolus Calculator before giving a bolus. The next time the user enters the Bolus Calculator, they are presented a screen (Figure 7) which can suggest an inaccurate bolus amount. We will provide new PDMs containing the software update to all Omnipod DASH™ users and will contact you when we are ready to ship your PDM. This voluntary action is being taken by Insulet Corporation with the knowledge of the U.S. Food and Drug Administration (FDA). Omnipod, the Omnipod logo, DASH, the DASH logo, HORIZON, the HORIZON Logo, Omnipod DISPLAY, Omnipod VIEW, Omnipod DEMO, Podder, Simplify Life, Toby the Turtle, PodderCentral, the PodderCentral logo, and PodderTalk are trademarks or registered trademarks of Insulet Corporation. Figure 7: Screen showing inaccurate bolus amount, Figure 8: Calculations showing inaccurate bolus amount based on old BG reading. My first impression of the Omnipod Dash insulin delivery system! Actual values will vary based on user input. We are adjusting our timing to ensure the software solution is implemented completely. All rights reserved. All other trademarks are the property of their respective owners. This notice is being issued as a precautionary measure. $240 for a box of ten through Omnipod without insurance coverage. A simple and discreet way to deliver insulin. If the user selects “Calculations”, the old BG reading is displayed for the correction bolus (Figure 8). With the Omnipod DISPLAY™ app, you can: • Monitor your insulin delivery and Omnipod DASH™ System status conveniently and discreetly from your smartphone. There are two specific scenarios where this may occur: Figure 2: User does not deliver a bolus and selects “Cancel”, Figure 3: User does not select “Yes” or “No” and the PDM screen goes to sleep, Figure 4: Screen showing inaccurate bolus amount, Figure 5: Calculations showing inaccurate bolus amount based on old BG reading. The Omnipod Horizon system uses CGM readings to automatically adjust basal insulin delivery. Ascensia, the Ascensia Diabetes Care Logo, and Contour are the trademarks and/or registered trademarks of Ascensia Diabetes Care. If you have any questions, please continue to visit our website at https://www.omnipod.com/insulet-alerts or call Insulet's 24/7 Customer Care at 1-800-581-6359. If the user selects “Calculations”, the old BG reading is displayed for the correction bolus (Figure 5). When the user activates a new Pod, the previously entered BG value will be used in the next bolus calculation. How could the Bolus Calculator not function as intended? If a user is unaware of this issue, the incorrect information may result in over- or under-delivery of insulin, which may lead to hypoglycemia or hyperglycemia. Editor's note: The headline and body of this article has been edited to clarify that Samsung's integration with the Omnipod Dash have not yet been implemented. The Total Bolus is calculated based on the old BG value, even though no BG is displayed on the screen. A software update will be made to the next version of Omnipod DASHTM PDM which will provide a solution for this issue and is expected to be available starting in March 2020. To upload your Omnipod DASH™ Part 1: Update the data file on your DASH PDM. For use with Omnipod ® Extension Software for the CoPilot Health Management System. Glooko is a trademark of Glooko, Inc. and used with permission. Fatalities? The Total Bolus should always be the sum of the Meal Bolus and Correction Bolus. If the user delivers the bolus that uses an outdated BG value, this may result in over or under delivery of insulin which may lead to hypoglycemia or hyperglycemia. OmniPod© DASH Peelz are designed for the OmniPod DASH™ Insulin Pump Management System. The Bluetooth® word mark and logos are registered trademarks owned by the Bluetooth SIG, Inc. and any use of such marks by Insulet Corporation is under license. Engineered to ensure a perfect fit that won’t obstruct buttons or sensors. The firm will be voluntarily providing a replacement PDM to all existing Omnipod DASH users. Before we enter into a full commercial release of the Omnipod DASH ™ System, we are embarking on a six-month, limited market release called the DASH ™ AHEAD Program. No c … The suggested dose may be too much or too little for the user, and if delivered by the user, may result in either hypoglycemia or hyperglycemia. Download the data on your Omnipod®PDM to your personal computer using Abbott Diabetes Care CoPilot®Health Management System to create custom charts and graphs that are easy to share with your healthcare provider. Easy to apply. Tap Done/OK. The use of third party trademarks does not constitute an endorsement or imply a relationship or other affiliation. Touchscreen PDM: DASH comes with a new PDM (Personal Diabetes Manager controller) that’s a “locked down” Android device, i.e. This action was taken voluntarily by Insulet with the knowledge of the FDA. You are receiving this letter as our records indicate that you are a current user of the Omnipod DASH™ System. Dash Pods 4.0 out of 5 stars 19. The firm will be making a software update to the next version of Omnipod DASH PDM which will provide a solution for this issue and is expected to be available starting March 2020. $16.91 $ 16. A software update is being developed to provide a solution for this issue and is expected to be available starting in. Share your data directly with your HCP and the rest of your care team to get support in between meetings. Pod Therapy may help make diabetes a smaller, more manageable part of your life. Toby’s T1D Tale™ mobile app is an educational resource geared towards kids to help them learn more about diabetes. All rights reserved. With Glooko, you can easily sync and view your diabetes data to identify trends and make data-driven treatment decisions. Note: The Figures above are for illustration purposes only. FREE Shipping on orders over $25 shipped by Amazon. Turn your DASH PDM off, then turn it back on. Manuals and User Guides for OmniPod DASH System. OmniPod Users Get Glooko For Free! The software version can be found on the “About” screen in the Omnipod DASH PDM menu. How did Insulet become aware of this Bolus Calculator issue? Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either at www.fda.gov/Safety/MedWatch or by regular mail or by fax. Use the USB-A to USB mini-B cable to download insulin pump data from your PDM to your computer. Users control the system directly from their smartphone. 50 ($17.50/Count) Get it as soon as Mon, Jan 11. When your replacement PDM is read to ship, you will receive an email notification. Bill pay function available for Podders™ with valid credit card information on file. The Omnipod DASH System has a suite of optional mobile apps for users, caregivers and HCPs to help simplify diabetes management. When your replacement PDM is read to ship, you will receive an email notification. Share your data directly with your HCP and the rest of your care team to get support in between meetings. If you have any questions, please visit our website at, In the Omnipod DASH™ PDM, the Bolus Calculator feature can be used to calculate a meal and/or correction bolus. COVID-19: view a video response from our CEO, Omnipod DASH® System Resources and Troubleshooting, Omnipod® System Resources and Troubleshooting. for updated information on the PDM replacement timing. Omnipod DASH™ Personal Diabetes Manager (PDM). $88.51. This will replace the old BG value and ensure an accurate dose is calculated based on the current BG. All other trademarks are the property of their respective owners. Omnipod DASH Insulin Management System, Product Catalog Number 18239 M/D: PDM USA1 D001 MG USA1 Code Information Lot Numbers L000120, L000121, L000122, L000123, L000124, L000131, L000132, L000133, L000135, L000136 This email will include shipment tracking details and important user resources (, If you have any questions, please continue to visit our website at, We will contact you when we are ready to ship your PDM. It is important to note that no injuries have been reported. It is important to note that no injuries have been reported. A user enters a BG value into the Bolus Calculator. Omnipod DASH™ System Mobile Apps and Data Management Mobile Apps and Data Management Software for the Omnipod DASH™ System The innovative Omnipod DASH™ System platform can be connected to the cloud through Wi-Fi and Bluetooth ® wireless technology. This connectivity enables a suite of mobile apps to better support diabetes management. The Omnipod DASH ® Insulin Management System is the first and only tubeless device that can provide 3 days of non-stop insulin delivery 2. The heart of the Omnipod® System is a small, wearable Pod which can deliver up to 72 hours of continuous insulin. This notification affects the Omnipod DASH™ PDM in the United States (software version 1.0.50 and earlier), and in the United Kingdom, Netherlands, and Italy (software version 1.0.1). In the U.S., the new PDMs are now expected to be available beginning in late June and continuing through the third quarter instead of March, as previously communicated. 91 ($0.68/Count) Get it as soon as Tue, Dec 29. Samsung Galaxy smartphones will be serving as the controlling device for Billerica, Massachusetts-based Insulet Corporation’s tubeless insulin pump devices, the two companies announced today. The app follows Omnipod ® System mascot Toby the Turtle™ from diagnosis to treatment as he, his family, and his friends learn how to manage diabetes. It said the Omnipad Dash system is still safe to use. Omnipod“ Dash Gel Skin- Soft Silicone Cover Designed to Protect The Omnipod Dash Device (Blue) 4.8 out of 5 stars 158. Pros and cons!Omnipod is a tubeless insulin pump. We will provide new PDMs containing the software update to all Omnipod DASH™ users and we will contact them directly when we are ready to ship. for updated information on the PDM replacement timing. ... 5 Pack Dash Pods 4.4 out of 5 stars 36. If you have Type 1 diabetes, or care for a child or adult with diabetes, then discover how the simplicity of the Omnipod DASH™ Insulin Management System may give you or the person you care for more freedom. We are reaching out to all global consumers and prescribers of Omnipod DASH to make them aware of the situation and provide clear, simple guidance on how to prevent this potential situation. If you have any questions, please visit our website at https://www.omnipod.com/insulet-alerts or call Insulet’s 24/7 Customer Care at 1-800-581-6359. No injuries have been reported as a result of the potential issue and the Omnipod DASH System is safe for continued use and distribution. HCP Quick Glance Guide PDF Pods available via retail or mail-order pharmacy. Figure 1: The timestamp associated with the BG value was greater than 10 minutes old, therefore the Omnipod DASH™ PDM does not allow the user to select Confirm at the bottom right of the Bolus Calculator screen to deliver the bolus. On rare occasions, the bolus calculator may use an old BG value that was entered more than 10 minutes prior and suggest an inaccurate bolus amount to the users. The PDM replacement will be sent to all Omnipod DASH users as part of Insulet’s voluntary Medical Device Correction. For podders without insurance coverage, you can still go through Omnipod and get financial assistance if applicable. We are voluntarily providing a replacement PDM to all Omnipod DASH™ users and we will contact you directly when we are ready to ship your PDM. Meet Omnipod DASH ®, a Pod-based insulin management system to help those living with Type 1 and Type 2, keep diabetes where they want it—in the background.Omnipod is a wireless, waterproof,* concealable alternative to traditional pumps that gives you … This does NOT affect the Omnipod DASH™ Pods or the widely distributed Omnipod® Insulin Management System. Our quick start guide walks you through getting started with Glooko, from installing the app and creating an account to viewing graphs and understanding reports. Yes, it is safe for users to continue using the Omnipod DASH™ PDM if the steps detailed above are followed to ensure incorrect information is not used to calculate the suggested bolus. Consumer safety is Insulet’s top priority and this action is taken voluntarily with the knowledge of the FDA. COVID-19: view a video response from our CEO  >. COVID-19: view a video response from our CEO  >. The Bluetooth® word mark and logos are registered trademarks owned by the Bluetooth SIG, Inc. and any use of such marks by Insulet Corporation is under license. Users can check their Omnipod DASH™ PDM’s software version on the “About” screen in the Omnipod DASH™ PDM menu. We are providing you with an update to the Medical Device Correction issued on Feb. 13, 2020. This does NOT affect the Omnipod DASH™ Pods or the widely distributed Omnipod® Insulin Management System. In line with this, we are writing to you with important safety information regarding the Omnipod DASH™ System’s Bolus Calculator. Before initiating the bolus, an alarm occurs on the Omnipod DASH. Insulet’s tubeless insulin delivery pod is a three-day-wear patch pump, which will communicate with a CGM to deliver insulin. If the user does not choose either option after 10 minutes, and the Omnipod DASH™ PDM screen is put to sleep or the screen times out, this old BG value will be used in the next bolus calculation. Care at 1-800-581-6359 this will replace the old BG reading is displayed on DASH... Calculate a meal and/or correction Bolus an educational resource geared towards kids to help users identify and avoid issue... Back on which day and time of day you are receiving this letter as our records indicate that are! 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Bolus, an alarm occurs on the DASH PDM to all Omnipod DASH™ users and Profile link beside name... Enter the current BG into the Bolus Calculator screen selects “ Cancel ” at the top-right of your Glooko app... Said the Omnipad DASH System omnipod dash software available for Podders™ with valid credit information! Can still go through Omnipod without insurance coverage 5 ) identify and avoid the issue &.! Being issued as a result of the appropriate local Health authorities always check “! Take several weeks to ship, you will receive an email notification PDF:... Autoimmunedisease # insulindependent # podder # Omnipod # omnipoddashHello everyone used to calculate meal. Enables a suite of mobile apps for users, caregivers and HCPs to help simplify diabetes Management!! Platform that makes diabetes Management easier to upload your Omnipod DASH™ System, Customer safety is Insulet ’ s priority. Time of day you are receiving this letter as our records indicate that you are this! Deliver insulin users can check their Omnipod DASH™ System note: you can also access your Profile by the... Also access your Profile by clicking the Profile link beside your name on the screen taken. Then turn it back on when your replacement PDM to your Android Device cancelled will!: view a video response from our CEO > version of Omnipod PDM! When we are writing to you with an update to the Medical Device correction System... Blue ) 4.8 out of 5 stars 36 with an update to the Bolus! It safe for users to continue using their Omnipod DASH™ System information directly on your DASH.... More with Subscribe & Save users identify and avoid the issue this is small!