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. 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. 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. 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. What is the expected experience with the Omnipod DASH™ PDM Bolus Calculator? Plug one end of your USB-A to Micro cable into your computer and the other end of your cable into your DASH PDM. 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. Select Settings. 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. You can also visit our website, www.omnipod.com 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. OmniPod© DASH Peelz are designed for the OmniPod DASH™ Insulin Pump Management System. 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. Get it as soon as Mon, Jan 11. 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. We are adjusting our timing to ensure the software solution is implemented completely. We are voluntarily providing a replacement PDM to all Omnipod DASH™ users and. Additionally, this potential situation does NOT affect the Omnipod DASH™ Pods or the widely distributed Omnipod® Insulin Management System. 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 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). doesn’t allow for other apps or cellular phone use. 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. Engineered to ensure a perfect fit that won’t obstruct buttons or sensors. Omnipod DASH™ Personal Diabetes Manager (PDM). Dash Pods 4.0 out of 5 stars 19. 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 Total Bolus is calculated based on the old BG value, even though no BG is displayed on the screen. To upload your Omnipod DASH™ Part 1: Update the data file on your DASH PDM. A software update is being developed to provide a solution for this issue and is expected to be available in the starting March 2020. COVID-19: view a video response from our CEO >. Glooko is a trademark of Glooko, Inc. and used with permission. A simple and discreet way to deliver insulin. Figure 7: Screen showing inaccurate bolus amount, Figure 8: Calculations showing inaccurate bolus amount based on old BG reading. You are receiving this letter as our records indicate that you are a current user of the Omnipod DASH™ System. Get it as soon as Mon, Jan 11. 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? Bill pay function available for Podders™ with valid credit card information on file. Download Toby’s … 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). • Use the 'Find… This does NOT affect the Omnipod DASH™ Pods or the widely distributed Omnipod® Insulin Management System. ; Click the drop-down menu at the top-right of your Glooko web app. ... 5 Pack Dash Pods 4.4 out of 5 stars 36. How could the Bolus Calculator not function as intended? How should I communicate this information to my patients? Insulet’s tubeless insulin delivery pod is a three-day-wear patch pump, which will communicate with a CGM to deliver insulin. It is important to note that no injuries have been reported. 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. 50 ($17.50/Count) Save more with Subscribe & Save. This potential situation does NOT affect the Omnipod DASH™ Pods or the widely distributed Omnipod® Insulin Management System. Insulet said it has no reports of injuries at this time. If you would like to sync data from other diabetes devices or to your Android device. With Glooko, you can easily sync and view your diabetes data to identify trends and make data-driven treatment decisions. #type1diabetes #autoimmunedisease #insulindependent #podder #omnipod #omnipoddashHello everyone! The software version can be found on the “About” screen in the Omnipod DASH PDM menu. Why are we issuing a Medical Device Correction? 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. NOTE: You can also access your Profile by clicking the Profile link beside your name on the Summary screen. The next time the user enters the Bolus Calculator, they are presented a screen (Figure 4) which can suggest an inaccurate bolus amount. Best seller at Pump Peelz - Constructed of durable yet eco-friendly vinyl that won’t leave a residue on your device. Always follow instructions on the Omnipod DASH™ PDM screen. 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). 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. 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. In line with this, we are writing to you with important safety information regarding the Omnipod DASH™ System’s Bolus Calculator. To upload your Omnipod® data. Is it safe for users to continue using the Omnipod DASH™ PDM? This will replace the old BG value and ensure an accurate dose is calculated based on the current BG. 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. 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. What do I do if I am currently using the Omnipod DASH™ System? With the Omnipod DISPLAY™ app, you can: • Monitor your insulin delivery and Omnipod DASH™ System status conveniently and discreetly from your smartphone. 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. On June 25th, we began shipping replacement PDMs to current users of the Omnipod DASH™ System within the United States. 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.