Recall record at a glance
| Official record | Z-2618-2023 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Ongoing |
| Recalling firm | Insulet Corporation |
| Report date | Sep 27, 2023 |
| Recall initiation date | Feb 28, 2023 |
| Quantity | 11,016 users |
| Location | Acton, MA, United States |
Official product description
Omnipod 5 Automated Insulin Delivery System
Why the product was recalled
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 Android smartphones and did not affect the Omnipod 5 Pods or the dedicated locked-down Controller provided by Insulet. All other Omnipod 5 users were still able to manage their insulin with the device without use of the smartphone app and affected users were able to switch to the locked-down control provided to all users when they initiated the device during the time the App was unavailable to them. Further, the Omnipod itself continued to deliver insulin as per its pre-programmed settings so although affected users who did not have the locked-down controller readily available may not have been able to command insulin boluses during this time, they continued to receive basal insulin without interruption. Lastly, users of the Omnipod 5 were advised during training to always have backup supplies ready in the event of a device malfunction which would include alternative means to deliver insulin subcutaneously until the issue is resolved to minimize disruption to their insulin regimen. There were 2,168 complaints received out of 7,838 users with the Android compatible smartphones affected and 9 MDRs were submitted, however, there were no serious injuries reported or reports of erroneous results as the primary issue was a delay in therapy. This defect cannot cause false results that could negatively impact patients.
Distribution information
Distribution throughout the US
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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