Insulet has alerted users of the Omnipod 5 Automated Insulin Delivery (AID) System about a potential fire hazard with the controller device’s battery charger.
The Medical Device Correction notice issued November 14 is not a recall; rather, users are advised to check the charging port on the controller to see if it is “melted, deformed, or discolored,” or if the device overheats or emits an odor while charging.
If any of these issues are detected, users are advised to disconnect the charger from the power outlet and not to charge the controller. Users who have Android phones with the Omnipod 5 app can switch to using that.
Otherwise, once the controller battery drains, users would be required to switch to a back-up insulin delivery plan. If this happens, they should call Insulet at 1-800-641-2049 to request a replacement.
The US Food and Drug Administration (FDA) approved use of the Omnipod 5 AID system for children aged 2 years and older with type 1 diabetes in August. It was originally cleared for use in individuals age 6 and older in January 2022, as previously reported by Medscape Medical News.
The affected products have part number PT-000409 and unique device identifier 10385083000022, with the issue applying to all serial numbers. Those numbers are located on the label on the back of the controller. The affected products began manufacturing and distribution in February 2022. The notice doesn’t apply to older Omnipod versions (DASH, Eros).
Users who are not experiencing any of the problems may continue to use their Omnipod 5 Controllers, with some additional instructions: place the device on a flat, heat-resistant surface while charging, inspect the charging port and cable for debris and clean it out if found, and take care when plugging/unplugging the device.
Users are also advised to only use the cable and power adapter that came with the Omnipod 5 Controller and to unplug once the battery reaches 100%.
“We are working diligently to determine the cause and appropriate solution to correct this issue. We will inform you via email and update our website when we have a solution…We understand this may impact your experience and are here to support you,” the letter concludes. It’s signed by Michael Spears, senior vice president, regulatory affairs & compliance, Insulet Corporation.
Miriam E. Tucker is a freelance journalist based in the Washington, DC, area. She is a regular contributor to Medscape, with other work appearing in The Washington Post, NPR’s Shots blog, and Diabetes Forecast magazine. She is on Twitter: @MiriamETucker.