If the user delivers the bolus, this may result in over or under delivery of insulin which may lead to hypoglycemia or hyperglycemia. 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 … Engineered to ensure a perfect fit that won’t obstruct buttons or sensors. Figure 7: Screen showing inaccurate bolus amount, Figure 8: Calculations showing inaccurate bolus amount based on old BG reading. My review of the *NEW* Omnipod DASH Insulin Pump system after wearing it for 3 days! If you have any questions regarding the information provided in this Medical Device Correction, please contact 1-800-581-6359. 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. 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. $17.50 $ 17. My first impression of the Omnipod Dash insulin delivery system! This potential situation does NOT affect the Omnipod DASH™ Pods or the widely distributed Omnipod® Insulin Management System. Easy to apply. All other trademarks are the property of their respective owners. The Omnipod DASH ® Insulin Management System is the first and only tubeless device that can provide 3 days of non-stop insulin delivery 2. ©2018-2020 Insulet Corporation. A software update will be made to the next version of Omnipod DASH. The Total Bolus should always be the sum of the Meal Bolus and Correction Bolus. Glooko is a trademark of Glooko, Inc. and used with permission. The Pod is controlled by a sleek Personal Diabetes Manager (PDM) which makes it simple to manage everyday tasks like carbohydrate counting, bolus doses and more. for updated information on PDM replacement timing. FREE Shipping on orders over $25 shipped by Amazon. for updated information on the PDM replacement timing. The Total Bolus is calculated based on the old BG value, even though no BG is displayed on the screen. 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. 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. 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. Download the Omnipod DASH® Glooko Quick Start Guide as a PDF, Connect a compatible Continuous Glucose Monitor (CGM) to Glooko by following these 3 simple steps, Download the Glooko CGM Integration Guide PDF. ©2018-2020 Insulet Corporation. Use the USB-A to USB mini-B cable to download insulin pump data from your PDM to your computer. 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. Download Toby’s … Fixic – Best Adhesive Patches for Omnipod – 25 PCS of Premium Patches with Waterproof Adhesive – Pre-Cut Back Paper – Adhesive Patch with a Belt for Omnipod – Extend The Life of Your Sensor! Have the appropriate health authorities in the US and EU (UK, NL, IT) markets been informed of this Medical Device Correction? This email will include shipment tracking details and important user resources (Settings Transfer Guide and Settings Transfer Video). 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. This notice affects the Omnipod DASH™ PDM (using software version 1.0.50 and earlier). 50 ($17.50/Count) Get it as soon as Mon, Jan 11. This voluntary action is being taken by Insulet Corporation with the knowledge of the U.S. Food and Drug Administration (FDA). The Omnipod DASH™ System will continue to be available in the United States, United Kingdom, Netherlands, and Italy. 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. 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. Share your data directly with your HCP and the rest of your care team to get support in between meetings. Go to my.glooko.com in your web browser and sign into your Glooko account. $17.50 $ 17. Select Settings. 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 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. Identify patterns and determine which day and time of day you are in the best control. Turn your DASH PDM off, then turn it back on. 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. 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. You can also visit our website, www.omnipod.com for updated information on the PDM replacement timing. In the Omnipod DASH™ PDM, the Bolus Calculator feature can be used to calculate a meal and/or correction bolus. Actual values will vary based on user input. In Scenario 1, selecting “Yes” or “No” when prompted to confirm the cancelled bolus will prevent this situation. The software version can be found on the “About” screen in the Omnipod DASH PDM menu. How could the Bolus Calculator not function as intended? Users can check their Omnipod DASH™ PDM’s software version on the “About” screen in the Omnipod DASH™ PDM menu. You are receiving this letter as our records indicate that you are a current user of the Omnipod DASH™ System. Always enter a current BG into the Bolus Calculator before giving a bolus. With Glooko, you can easily sync and view your diabetes data to identify trends and make data-driven treatment decisions. When your replacement PDM is read to ship, you will receive an email notification. Always enter the current BG into the Bolus Calculator before giving a bolus. Does this change the continued distribution of the Omnipod DASH™ System? Toby’s T1D Tale™ mobile app is an educational resource geared towards kids to help them learn more about diabetes. As the manufacturer of the Omnipod DASH™ System, customer safety is Insulet Corporation’s top priority. This simple, easy to use system lets you live life on your terms, free from the hassles of tubing and daily injections. 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. $240 for a box of ten through Omnipod without insurance coverage. The next time the user enters the Bolus Calculator, they are presented a screen (Figure 4) which can suggest an inaccurate bolus amount. Tap Done/OK. NOTE: You can also access your Profile by clicking the Profile link beside your name on the Summary screen. 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). All rights reserved. This notice is being issued as a precautionary measure. 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. A software update is being developed to provide a solution for this issue and is expected to be available in the starting March 2020. OmniPod Users Get Glooko For Free! 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. A user enters a BG value into the Bolus Calculator. 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. Omnipod“ Dash Gel Skin- Soft Silicone Cover Designed to Protect The Omnipod Dash Device (Blue) 4.8 out of 5 stars 158. $88.51. 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. No c … 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 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). Get it as soon as Mon, Jan 11. ; Click the drop-down menu at the top-right of your Glooko web app. 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. 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. 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. 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. Download the free Glooko mobile app onto your iOS or Android smartphone or tablet, and create an account to get started. If you would like to sync data from other diabetes devices or to your Android device. 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. Premium print quality brings each design to life. Plug one end of your USB-A to Micro cable into your computer and the other end of your cable into your DASH PDM. 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. for updated information on the PDM replacement timing. 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. Insulet’s tubeless insulin delivery pod is a three-day-wear patch pump, which will communicate with a CGM to deliver insulin. 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. Scroll down to the Apps & Devices section, and click Upload Omnipod® PDM. Senior Vice President, Regulatory Affairs & Compliance. About Insulet Corporation: $17.50 $ 17. How do you prevent the user from giving an inaccurate bolus? Tap Export on the DASH PDM to export your data. It is important to note that no injuries have been reported. 91 ($0.68/Count) Get it as soon as Tue, Dec 29. This is a voluntary action and it may take several weeks to ship the replacement PDMs. Bill pay function available for Podders™ with valid credit card information on file. • Use the 'Find… The firm will be voluntarily providing a replacement PDM to all existing Omnipod DASH users. What is the expected experience with the Omnipod DASH™ PDM Bolus Calculator? From extensive testing and analysis, the likelihood of this sequence of events occurring is considered very low. In the Omnipod DASH™ PDM, the Bolus Calculator feature can be used to calculate a meal and/or correction bolus. Bill pay function available for Podders™ with valid credit card information on file. A software update is being developed to provide a solution for this issue and is expected to be available starting in. 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. For this reason, this notice has been issued to help users identify and avoid the issue. All rights reserved. We make almost $100,000 yearly and still get assistance with this. 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. 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. doesn’t allow for other apps or cellular phone use. 50 ($17.50/Count) Save more with Subscribe & Save. FREE Shipping on orders over $25 shipped by Amazon. We are voluntarily providing a replacement PDM to all Omnipod DASH™ users and. 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. 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. A software update is being developed to provide a solution for this issue and is expected to be available starting in March 2020. Pod Therapy may help make diabetes a smaller, more manageable part of your life. Ascensia, the Ascensia Diabetes Care Logo, and Contour are the trademarks and/or registered trademarks of Ascensia Diabetes Care. The Omnipod Horizon system uses CGM readings to automatically adjust basal insulin delivery. We are adjusting our timing to ensure the software solution is implemented completely. 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.