The FDA is alerting users and providers to Tandem Diabetes Care’s recall of its insulin pump-controlling iPhone app after a software bug was found to quickly drain the pump’s battery.
While no products need to be returned to the manufacturer, the agency is flagging the need for an update as a Class I recall, its most serious category, due to the risks posed by an inoperable pump to people with diabetes.
According to the FDA, 224 injuries have been reported as of mid-April following potential interruptions to insulin delivery, with zero reports of user deaths out of more than 85,000 active downloads. The pump, indicated for users ages 6 and up, is designed to notify users about low battery levels ahead of time.
Version 2.7 of the company’s t:connect app was first launched for Apple iOS in February, to link the user’s smartphone with its t:slim X2 insulin pump. However, an issue may cause the program to crash and be automatically relaunched—this repeating cycle can lead to additional Bluetooth communication with the pump, depleting its power and causing it to shut down sooner than expected, the FDA said.
Tandem began its public recall efforts on March 26, with a letter urging users (PDF) to update their t:connect apps to version 2.7.1 or later through the Apple App Store. The issue does not affect Android users. At that time, Tandem said it was aware of one reported injury that required medical intervention.
“We continue to make every effort to contact everyone who has not yet updated their iOS app to the new version,” Tandem said in a statement to Fierce Medtech.
The company also recommended that pumps be fully charged before going to sleep, and that users should carry backup insulin supplies in case the pump fails. With average use, the t:slim X2’s battery should last between four to seven days, less when connected to a continuous glucose monitor, though battery life can also vary based on the frequency of insulin delivery and scheduled reminders.
Insufficient insulin can result in hyperglycemia or even diabetic ketoacidosis, which can become life-threatening, the FDA said.
Earlier this month Tandem released its first quarter earnings, posting $191.7 million in revenue for a 13% gain over the prior year, while worldwide pump shipments grew 9% to about 25,000 units.
This past quarter saw the t:slim X2 pump integrate with continuous glucose monitors from Abbott and Dexcom, to adjust insulin delivery based on the sensors’ blood sugar readings. The company also kicked off the launch of its miniaturized Mobi wearable pump, cleared for users as young as 2 years old.