Class 2 Device Recall Omnipod 5 Automated Insulin Delivery System

• Date Initiated by Firm: February 28, 2023
• Date Posted: September 20, 2023
• Recall Status: Open, Classified
• Recall Number: Z-2618-2023
• Recall Event ID: 92909
• 510(K)Number: K203768
• Product Classification: Alternate controller enabled insulin infusion pump - Product Code QFG
• Product: Omnipod 5 Automated Insulin Delivery System
• Code Information: PT-000559 Omnipod 5 App; all versions of software installed UDI-DI: 10385081120302
• Recalling Firm/ Manufacturer: Insulet Corporation; 50 & 100 Nagog Park; Acton MA 01720-3440
• For Additional Information Contact: 978-600-7451
• Manufacturer Reason for Recall: 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.
• FDA Determined 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 in Commerce: 11,016 users
• Distribution: Distribution throughout the US
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = QFG