for updated information on PDM replacement timing. What is the expected experience with the Omnipod DASH™ PDM Bolus Calculator? 91 ($0.68/Count) Get it as soon as Tue, Dec 29. Omnipod PDM data can also be uploaded and viewed in Tidepool's data management system. 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. This will replace the old BG value and ensure an accurate dose is calculated based on the current BG. 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. 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. This email will include shipment tracking details and important user resources (Settings Transfer Guide and Settings Transfer Video). 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. 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. You are receiving this letter as our records indicate that you are a current user of the Omnipod DASH™ System. ; Click the drop-down menu at the top-right of your Glooko web app. 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. 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. With the Omnipod DISPLAY™ app, you can: • Monitor your insulin delivery and Omnipod DASH™ System status conveniently and discreetly from your smartphone. Pod Therapy may help make diabetes a smaller, more manageable part of your life. 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. Omnipod DASH™ Personal Diabetes Manager (PDM). A software update is being developed to provide a solution for this issue and is expected to be available starting in. Premium print quality brings each design to life. 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. 4.1 out of 5 stars 28. Plug one end of your USB-A to Micro cable into your computer and the other end of your cable into your DASH PDM. Engineered to ensure a perfect fit that won’t obstruct buttons or sensors. For this reason, this notice has been issued to help users identify and avoid the issue. From extensive testing and analysis, the likelihood of this sequence of events occurring is considered very low. 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). 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 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. 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). A software update is being developed to provide a solution for this issue, which is expected to be available starting March 2020. Ascensia, the Ascensia Diabetes Care Logo, and Contour are the trademarks and/or registered trademarks of Ascensia Diabetes Care. How do you prevent the user from giving an inaccurate bolus? This notice affects the Omnipod DASH™ PDM (using software version 1.0.50 and earlier). 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. Actual values will vary based on user input. Users can check their Omnipod DASH™ PDM’s software version on the “About” screen in the Omnipod DASH™ PDM menu. The Total Bolus should always be the sum of the Meal Bolus and Correction Bolus. After selecting “Cancel”, a prompt asks the user “Are you sure you want to cancel?” with the options “Yes” or “No” (Figure 3). This does NOT affect the Omnipod DASH™ Pods or the widely distributed Omnipod® Insulin Management System. Always enter a current BG into the Bolus Calculator before giving a bolus. 50 ($17.50/Count) Save more with Subscribe & Save. Note: The Figures above are for illustration purposes only. For use with Omnipod ® Extension Software for the CoPilot Health Management System. 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. Enter your PIN Code to unlock your DASH. 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. When your replacement PDM is read to ship, you will receive an email notification. The PDM replacement will be sent to all Omnipod DASH users as part of Insulet’s voluntary Medical Device Correction. The Figures above are for illustration purposes only. You can also visit our website, www.omnipod.com for updated information on the PDM replacement timing. As the manufacturer of the Omnipod DASH™ System, customer safety is Insulet Corporation’s top priority. $88.51. 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. We make almost $100,000 yearly and still get assistance with this. Touchscreen PDM: DASH comes with a new PDM (Personal Diabetes Manager controller) that’s a “locked down” Android device, i.e. 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. Turn your DASH PDM off, then turn it back on. We have 1 OmniPod DASH System manual available for free PDF download: Quick Start Manual . 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. COVID-19: view a video response from our CEO, Omnipod DASH® System Resources and Troubleshooting, Omnipod® System Resources and Troubleshooting. 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. $17.50 $ 17. All other trademarks are the property of their respective owners. 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. 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. 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. 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. Senior Vice President, Regulatory Affairs & Compliance. The heart of the Omnipod® System is a small, wearable Pod which can deliver up to 72 hours of continuous insulin. Download the free Glooko mobile app onto your iOS or Android smartphone or tablet, and create an account to get started. This action and communication are being taken voluntarily and with the knowledge of the appropriate local health authorities. ‎Omnipod DISPLAY™ is an application that displays your Omnipod DASH™ System information directly on your iOS smartphone. Everything you need, on the go! How did Insulet become aware of this Bolus Calculator issue? Consumer safety is Insulet’s top priority and this action is taken voluntarily with the knowledge of the FDA. The user selects “Cancel” at the bottom of the Bolus Calculator screen. A software update will be made to the next version of Omnipod DASH. Use the USB-A to USB mini-B cable to download insulin pump data from your PDM to your computer. #type1diabetes #autoimmunedisease #insulindependent #podder #omnipod #omnipoddashHello everyone! 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. HCP Quick Glance Guide PDF Pods available via retail or mail-order pharmacy. A user enters a BG value into the Bolus Calculator. The cleared indication for the Omnipod DASH System states that the pump is able to reliably and securely communicate with compatible, digitally … 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. 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. It said the Omnipad Dash system is still safe to use. My first impression of the Omnipod Dash insulin delivery system! 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. Fatalities? This potential situation does NOT affect the Omnipod DASH™ Pods or the widely distributed Omnipod® Insulin Management System. The Omnipod DASH System has a suite of optional mobile apps for users, caregivers and HCPs to help simplify diabetes management. Dash Pods 4.0 out of 5 stars 19. A user enters a BG value into the Bolus Calculator and does not deliver a bolus (Figure 2). OmniPod© DASH Peelz are designed for the OmniPod DASH™ Insulin Pump Management System. The use of third party trademarks does not constitute an endorsement or imply a relationship or other affiliation. We are voluntarily providing a replacement PDM to all Omnipod DASH™ users and. How could the Bolus Calculator not function as intended? Users control the system directly from their smartphone. Select Settings. The Omnipod DASH™ System will continue to be available in the United States, United Kingdom, Netherlands, and Italy. Insulet's Omnipod system includes a wearable pod that delivers insulin doses and a controller that looks like a smartphone, called the Omnipod DASH … Pros and cons!Omnipod is a tubeless insulin pump. Omnipod DASH™ simplifies living with diabetes! Best seller at Pump Peelz - Constructed of durable yet eco-friendly vinyl that won’t leave a residue on your device. NOTE: You can also access your Profile by clicking the Profile link beside your name on the Summary screen. We are providing you with an update to the Medical Device Correction issued on Feb. 13, 2020. 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. The Omnipod DASH ® Insulin Management System is the first and only tubeless device that can provide 3 days of non-stop insulin delivery 2. All rights reserved. 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 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). 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. No c … It is important to note that no injuries have been reported. $17.50 $ 17. In the Omnipod DASH™ PDM, the Bolus Calculator feature can be used to calculate a meal and/or correction bolus. Tap Done/OK. 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. To upload your Omnipod DASH™ Part 1: Update the data file on your DASH PDM. Tap Export on the DASH PDM to export your data. ©2018-2020 Insulet Corporation. Easy to apply. FREE Shipping on orders over $25 shipped by Amazon. If you would like to sync data from other diabetes devices or to your Android device. About Insulet Corporation: Share your data directly with your HCP and the rest of your care team to get support in between meetings. Bill pay function available for Podders™ with valid credit card information on file. The Total Bolus is calculated based on the old BG value, even though no BG is displayed on the screen. OmniPod Users Get Glooko For Free! Get it as soon as Mon, Jan 11. The Omnipod Horizon system uses CGM readings to automatically adjust basal insulin delivery. The next time the user enters the Bolus Calculator, they are presented a screen (Figure 7) which can suggest an inaccurate bolus amount. 50 ($17.50/Count) Get it as soon as Mon, Jan 11. Actual values will vary based on user input. A simple and discreet way to deliver insulin. 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. for updated information on the PDM replacement timing. This notice is being issued as a precautionary measure. This connectivity enables a suite of mobile apps to better support diabetes management. Before initiating the bolus, an alarm occurs on the Omnipod DASH. If the user delivers the bolus, this 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. 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. 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