Recall Z-0591-2024 ยท QFG Alternate Controller Enabled Insulin Infusion Pump
Insulet Corporation
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.
| Date | Jan 4, 2024 (initiated Nov 30, 2023) |
| Status | Open, Classified |
| 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. |
| Root cause | Software design |
| 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 Deliv |
| Quantity | 27000 users |
| Distribution | Worldwide distribution - US Nationwide and the countries of Germany and UK. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K231826 | Omnipod 5 ACE Pump Insulet Corporation, Oct 18, 2023 |