Recall Z-2618-2023 ยท QFG Alternate Controller Enabled Insulin Infusion Pump
Insulet Corporation
Omnipod 5 Automated Insulin Delivery System
| Date | Sep 20, 2023 (initiated Feb 28, 2023) |
| Status | Open, Classified |
| Reason | An error message was received when using the Omnipod 5 App on compatible smartphones that prevented phone control users from controlling the Omnipod 5 Automated Insulin Delivery System from their Omnipod 5 App which may cause a delay in therapy. To reduce the volume of inquiries Insulet was receiving from customers, an email was sent to all phone control users and the cause of the error message was resolved by reverting to prior certificates on the Insulet cloud to secure communications between the Omnipod 5 App sotware and the Insulet Cloud. This issue was limited to only certain compatible A |
| Root cause | Software Design Change |
| Action | Insulet emailed all phone control users on February 28, 2023 that an investigation into the issue was underway. Insulet determined root cause and resolved the issue early on March 1, 2023. Insulet sent a follow up email to all phone control users on March 1 to notify them that the issue had been resolved. |
| Quantity | 11,016 users |
| Distribution | Distribution throughout the US |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K203768 | Omnipod 5 ACE Pump (Pod) Insulet Corporation, Jan 27, 2022 |