The U.S. Food and Drug Administration (FDA) has issued a statement regarding the Class I recall for an iOS app used alongside insulin pumps, following 224 reported injuries. The mobile app in question is version 2.7 of t:connect, which is compatible with the t:slim X2 insulin pump with Control-IQ technology.

While the FDA clarified that this recall is a correction rather than a complete product removal, over 86,000 devices have already been recalled in the United States alone. Tandem Diabetes Care Inc., the developer of the app, initiated the recall due to a software issue, which could cause the app to crash and relaunch continuously. This issue leads to excessive Bluetooth communication, draining the battery life of the insulin pump and potentially causing it to shut down abruptly.

The sudden shutdown of the pump could result in a delay in insulin delivery to the body, creating life-threatening situations for users. Conditions such as hyperglycemia or diabetic ketoacidosis may arise as a consequence. In response, Tandem Diabetes Care Inc. has sent a letter to all affected users, urging them to update the software to version 2.7.1 or later.

The updated version of the app is currently available for download on the Apple App Store. Additionally, users are required to complete an online form to confirm that they have received the recall notice. It is strongly advised for users to closely monitor the battery level of their insulin pump at all times. The FDA also recommends having backup supplies for insulin delivery in case of persistent pump failure.

Tandem Diabetes Care Inc. has set up a dedicated helpline at (877) 801-6901 for customers with any queries or concerns related to the recall. Users are encouraged to reach out to the company for further assistance.

The FDA is working closely with Tandem Diabetes Care Inc. to ensure the appropriate actions are taken to rectify the software issue and minimize any potential harm to patients using the affected insulin pump app. It is crucial for users to follow the instructions provided and to promptly update their app to ensure the safe and effective functioning of their pump system.