Insulet’s recall — a correction, not a product removal — affects software versions 1.1-1.2.3 for the Omnipod 5 automated insulin delivery system. It distributed the software between April 20, 2023, and Dec. 20, 2023. The company initiated the recall, which affects 28,919 devices in the U.S., on Nov. 7, 2023.
The Omnipod 5 App uses SmartAdjust technology to help adjust insulin delivery based on real-time and future blood sugar levels. Its SmartBolus Calculator computes recommended bolus doses, while the app considers user-inputted carbohydrates and other sensor data. The recalled app is an Android-based software provided on either a locked-down controller or downloaded on a smartphone. Its uses include activating/deactivating pods, displaying alerts/alarms and sending insulin delivery commands.
Insulet recalled the app due to a software error. This error occurs when the user enters a bolus amount less than one unit without putting a leading zero before the decimal point. Due to this error, when entering a bolus dose of less than one unit, the SmartBolus Calculator fails to register the decimal point if it’s the first character entered.
For example, if a user enters “.2” when attempting to request 0.2 units, the app would fail to register the decimal point. Instead, it would display two units as the requested bolus. If a user enters “.20” units, the app could display 20 units. This could lead to the app giving too much insulin — anywhere from 10 times to up to 100 times the intended amount.
The company reports two injuries and zero deaths as a result of the software error.
Insulet requested that customers follow instructions when changing a suggested bolus. They should always visually confirm the bolus amount. The company released a software update (v1.2.4) on Dec. 7 to address and correct the issue. Users should have received a message that an update was required and that, following Dec. 20, the application wouldn’t be available until they performed the update.
