The U.S. Food and Drug Administration (FDA) issued a Class I recall t:connect, an iOS app used to control an insulin pump called t:slim x2, after injuring 224 users.
The diabetes mobile app experienced a glitch and drained the battery of the insulin pump that was connected to the app, resulting in a failed delivery of insulin to patients.
FDA Sets Class I Recall on t:connect Diabetes App
According to the FDA, Class I recall is the most serious type among all recalls. The agency identified the recall to warn customers that using the device could lead to serious injuries or death.
The reason for the recall is due to an issue with the software that may cause the mobile app to crash and be automatically relaunched by the iOS operating system," FDA explained. The repetitive cycle has caused excessive usage of Bluetooth which drained the battery, leading to pump shutdown.
Once the pump fails to function, the insulin delivery will not push through. Such cases could lead to hyperglycemia or diabetic ketoacidosis, a life-threatening condition. The FDA recorded 224 injuries and no deaths as of April 15.
FDA Reminds Users to Closely Monitor Pump Battery
FDA announced that the users of version 2.7 of t:connect which is connected to t:slim x2 insulin pump with Control-IQ technology must monitor closely the battery of their pumps to ensure safety and prevent sudden shutdown while sleeping.
The recall is affecting around 85,863 devices. Last March 26, Tandem Diabetes Care issued an Urgent Medical Device Correction to its users. Patients and medical practitioners who rely on the app must update their app to version 2.7.1 or later.
In addition, users are also advised to start charging their devices after the first low battery alert. They are also instructed to carry backup insulin delivery supplies in the case of pump failure.
