FDA Recall Open, Classified

Omnipod 5 App (on compatible Android smartphones), Software Versions 1.1 - 1.2.3 (current). US: PT-000599- Omnipod 5 App Software Package (provided through Google Play), EU: PT-001323- Omnipod 5 App Software Package (provided on locked-down Controllers (PT-001194 and PT-001193). Used to control an insulin pump.

Recall: Z-0591-2024 · Initiated November 30, 2023

Recall

Recall Number: Z-0591-2024
Event Number: 93511
FEI Number: 3014585508
Product Code: QFG
Status: Open, Classified
Root Cause: Software design
Initiated: November 30, 2023
Posted: January 4, 2024
Address: Corporation 50, Insulet &, Nagog Park Acton, MA, 01720-3440

Description

Reason

The bolus calculator is not recording the decimal point if it is the first value entered when changing a bolus dose. This may lead to an over-delivery of insulin to the user if the user does not recognize the error on the bolus calculator screen or the confirmation screen prior to starting the bolus.

Action

An URGENT: Medical Device Correction notification letter was sent customers on 11/30/23 via email. How do you avoid giving the wrong bolus amount? 1. When changing a bolus dose to less than 1 unit, always enter a zero (0) before the decimal (e.g., enter 0.3 instead of .3) (Figure 1) 2. Always check the bolus amount shown in the Total Bolus box before tapping CONFIRM 3. Double-check the amount on the Confirm Bolus screen (Figure 2) to make sure this is the amount you want to deliver before pressing START to deliver the bolus 4. Check the amount again while the bolus is in progress on the Delivering Bolus screen (Figure 3) As stated in our User Guide, it is important to review the bolus amount before you confirm and start the bolus. The Omnipod 5 App will always deliver the amount you confirm and that is shown on the Confirm Bolus screen (Figure 2). This amount can also be checked while the bolus is in progress on the Delivering Bolus screen (Figure 3). If it s not the amount you expected, you can always CANCEL the bolus. To check how much insulin has been delivered, check the Last Bolus box on the home screen or your History Detail. When will the issue be fixed? We are working diligently to correct this issue and expect a software update as soon as possible. We will inform your patients via email and update our website when available. Once available, the update will be pushed to their device, and they will not lose settings or history because of this update. We understand this may impact your experience and are here to support you. If you have any questions regarding the information provided in this Medical Device Correction, please call 800-591-3455 to speak with a member of the Insulet Customer Care team who are available 24 hours a day, 7 days a week.

Distribution

Worldwide distribution - US Nationwide and the countries of Germany and UK.

Quantity

27000 users