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Omnipod 5 Automated Insulin Delivery System recallZ-2618-2023 · Insulet Corporation · initiated Feb 28, 2023

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Insulet Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it 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.

FDA root cause category: Software Design Change

What the company is doing

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.

Recall details

Recall number
Z-2618-2023
Status
Open, Classified
Initiated by the company
Feb 28, 2023
Posted by the FDA
Sep 20, 2023
Recalling firm
Insulet Corporation
Quantity
11,016 users
Product code
QFG
FDA submissions
K203768
Distribution
Distribution throughout the US

Product description

Omnipod 5 Automated Insulin Delivery System

Code information (models, lots, serial numbers)

PT-000559 Omnipod 5 App; all versions of software installed UDI-DI: 10385081120302

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Sources and updates

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