Omnipod 5 Android App Recalled Due to Insulin Overdose Risk

Federal health officials have announced a class I recall of the Omnipod 5 Android App, which is designed to control certain insulin delivery systems, due to a risk that software errors may cause the devices to provide incorrect doses of insulin to users, increasing the risk of severe and potentially fatal injuries.

The U.S. Food & Drug Administration has issued the Omnipod 5 Android App recall on November 7, 2023, after discovering problems with the software may allow users to administer up to ten times the desired insulin dose from Insulet’s Omnipod 5 automated pump.

Officials are warning that an accidental over delivery of insulin could result in both mild and severe hypoglycemia. Symptoms of mild hypoglycemia include sweating, clamminess, chills, dizziness, confusion, anxiety, rapid heartbeat, hunger, irritability, blurred vision, and tingling of the mouth. Severe reactions to an increased insulin dosage could potentially result in a hypoglycemic coma, which, in extreme cases, may lead to death.

Omnipod 5 Android App Recall

The recall impacts the Omnipod 5 App that is used to control insulin dosages delivered through the Omnipod 5 system for individuals two years of age or older with type I diabetes. The app utilizes ‘SmartAdjust’ technology, which adjusts the insulin delivery based on current and future blood sugar levels.

Officials are warning that when the user enters a bolus amount less than 1 unit without including a leading zero before the decimal point, the app may fail to register the decimal point correctly. As a result, the app will send a command to deliver insulin at the level of the first character entered, rather than the intended amount.

If a user enters ‘.3’ with the intention of requesting a 0.3 unit insulin bolus, the app, unable to register the decimal point, would deliver 3 units of insulin instead of the intended 0.3. This situation could potentially result in an insulin overdose, if the user fails to recognize the error on the calculator screen or the confirmation screen before confirming the dose.

The recall impacts approximately 28,919 Omnipod Systems that were distributed for sale between April 20, 2023 and December 20, 2023.

On December 7, 2023, the manufacturer released a software update to address and correct the issue, and issued a Medical Device Correction notice to all registered customers. The letter requested that customers update the Omnipod 5 Android App to version 1.2.4 and confirm that the displayed insulin bolus amount matches the desired amount.

Customers with further questions about this recall should contact Insulet Customer Care at 1-800-591-3455.