Software bug in insulin pump app linked to injury of over 200 people; FDA issues urgent recall

A software glitch in the widely used insulin pump iOS mobile app, t:connect, has been linked to more than 200 injuries, prompting the US Food and Drug Administration (FDA) to issue a critical recall. This mobile app is used to control the t:slim X2 insulin pump, a device for regulating blood sugar levels in diabetic patients.

The FDA took action on Wednesday, announcing a Class I recall for the t:connect mobile app on iOS, used to monitor and regulate the t:slim X2 insulin pump in diabetic patients. Notably, this app was the first of its kind approved by the FDA for programming insulin doses. The recall was classified at the highest level due to significant software issues posing potentially life-threatening risks.

Although there were no reported fatalities, the FDA received 224 injury reports associated with the app malfunction as of April 15. The FDA’s prompt response in issuing a Class I recall underscores the severity of the situation, urging users of t:slim X2 insulin pumps with the t:connect mobile app to promptly update to the latest version, monitor battery levels vigilantly, and ensure emergency insulin reserves are readily available.

“The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death, the agency said on its website.

In its “Reason for Recall,” the FDA said:

Tandem Diabetes Care, Inc. is recalling version 2.7 (released February 12, 2024 on the Apple iOS platform) of the t:connect mobile app used in conjunction with t:slim X2 insulin pump with Control-IQ technology by correction. 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. This cycle intermittently repeats, which leads to excessive Bluetooth communication that may result in pump battery drain and may lead to the pump shutting down sooner than typically expected.

Pump shutdown will cause insulin delivery to suspend, which could lead to an under-delivery of insulin and may result in hyperglycemia or even diabetic ketoacidosis, which can be a life-threatening condition due to high blood sugars and lack of insulin. There have been 224 reported injuries as of April 15, 2024 and no reports of death.”

The issue originated from a bug within version 2.7 of the t:connect app for iOS devices, causing frequent crashes and relaunches. While seemingly minor, this continuous restarting led to excessive Bluetooth communication between the app and the pump, resulting in rapid depletion of the pump’s battery and unexpected shutdowns.

Given that insulin pumps are designed for continuous insulin delivery, such unexpected shutdowns disrupt the critical insulin flow, potentially leading to dangerous conditions like hyperglycemia and diabetic ketoacidosis. The malfunctioning app initiated a cycle of crashes and relaunches, escalating Bluetooth communication and prematurely draining the pump’s battery, as outlined by the FDA.

Insulin pumps such as the t:slim X2 are engineered to automatically administer insulin at scheduled intervals, alleviating users from frequent manual injections and managing glucose levels. However, a sudden pump shutdown could lead to insufficient insulin delivery, heightening the risk of hyperglycemia and diabetic ketoacidosis, as emphasized in the FDA’s recall notice.

Tandem Diabetes Care, the company responsible for the app and pump, issued an emergency notice to affected customers in March, advising them to update their app, closely monitor battery levels, and maintain backup insulin supplies. Despite this, the FDA’s recall notice serves as a critical alert for potentially overlooked or disregarded warnings, given past instances where malfunctioning insulin pumps resulted in fatalities.