The Recall Desk
HighFDA (Devices)·Z-2618-2023·Announced 2023-09-27

Omnipod 5 App Software Error Prevented Control on Android Phones

Omnipod 5 app users on certain Android phones encountered an error that prevented remote control of the insulin delivery system. The issue delayed therapy access but did not interrupt automatic insulin delivery, and was resolved by Insulet restoring cloud security settings.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II medical device where no serious injuries or erroneous insulin delivery were reported, despite potential for therapy delay. This fits the rubric for Score 3 as a risk-of-harm product where injury has not yet been reported, with mitigating factors including continued automatic basal delivery and available backup control methods.

Plain-English summary

The Omnipod 5 Automated Insulin Delivery System's smartphone app experienced a technical error on certain Android phones that prevented users from controlling the device remotely through the app. This error did not affect the system's automatic basal insulin delivery or the dedicated physical controller provided with the device.

The issue was reported by 2,168 users among approximately 7,838 users with compatible Android smartphones. Although 9 adverse event reports were filed, no serious injuries or erroneous insulin deliveries were reported. The impact was limited to a delay in therapy access—users could not send insulin boluses through the app.

Users had two backup control methods available during the app outage: the dedicated controller that comes with every Omnipod 5 system, and backup insulin supplies that patients are trained to maintain. The device itself continued automatically delivering preprogrammed basal insulin, ensuring patients received essential insulin throughout the issue.

Insulет resolved the error by restoring security settings on its cloud servers to restore communication between the Omnipod 5 app and its servers. Affected users were notified by email that the issue was resolved and app functionality was fully restored.

The recalled product

Product
Omnipod 5 Automated Insulin Delivery System
Manufacturer
Insulet Corporation
Category
Medical Device — Insulin Delivery System
Hazard
  • app-error
  • control-failure
  • therapy-delay

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

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

Distribution

Distribution scope not specified by the agency.

Related recalls

Same category