Insulet Corporation has voluntarily issued a Medical Device Correction for the Omnipod 5 Automated Insulin Delivery System due to an issue with the Omnipod 5 Controller charging port and cable.

The Omnipod® 5 System is cleared for patients 2 years of age and older with type 1 diabetes. The system consists of a tubeless, waterproof, wearable Pod, the Dexcom G6 Continuous Glucose Monitoring system (sold separately), and the Omnipod 5 mobile app or Controller.

The correction is regarding the Omnipod 5 Controller charging port (USB-C port) or cable (USB cable) melting, deforming, or discoloring due to heat generated by a poor connection between the cable and the port. The excess heat may cause minor burns or could lead to a fire. The affected product, Omnipod 5 Controller; Part Number PT-000409; UDI 10385083000022; all serial numbers, was distributed beginning February 2022. 

Omnipod 5 Issues To Date

To date, there have been 24 reports related to this issue with no serious injuries reported. The Company has notified users of the Omnipod 5 Automated Insulin Delivery System by email to provide instructions on how to detect and reduce the risk of an issue with the charging port or cable.

Individuals who experience this issue should disconnect the charger from the power outlet and not charge the Omnipod 5 Controller. Patients with a compatible Android smartphone can switch to using the Omnipod App.

This issue does not impact the Omnipod 5 Pod, the Omnipod® DASH Insulin Management System, the Omnipod® Insulin Management System, or compatible Android smartphone devices that have the Omnipod 5 App installed. 

References

  1. Insulet issues a nationwide voluntary Medical Device Correction for the Omnipod® 5 Controller. News release. Insulet Corporation. November 14, 2022. Accessed November 16, 2022. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/insulet-issues-nationwide-voluntary-medical-device-correction-omnipodr-5-controller
  2. Medical Device Correction. Urgent Information Regarding the Omnipod® 5 Automated Insulin Delivery System. Omnipod.com. Accessed November 16, 2022. https://www.omnipod.com/fsn-11-2022