The US Food and Drug Administration (FDA) has issued a Class I recall for the t:connect mobile app on iOS, which is used to monitor and control the t:slim X2 insulin pump used by people with diabetes. It was supposedly the first smartphone app that can program insulin doses that the FDA had approved. The agency issued the highest level of recall it could, because the app had serious software problems that could’ve have caused life-threatening conditions or even death. In fact, while there were no mortalities reported, the FDA received 224 injury reports as of April 15.
According to the agency, version 2.7 of the t:connect mobile app had a bug that initiated a cycle wherein the app would crash and then would be relaunched by the iOS platform again and again. That apparently led to excessive Bluetooth communication that would drain the pump’s battery and cause it to shut down earlier than the user would expect. Insulin pumps like the t:slim X2 are designed to automatically deliver insulin under the user’s skin at set time intervals and whenever needed. They’re supposed to take on the burden of managing the user’s sugar levels so that they can go about their day without having to stop and inject themselves or if they’re prone to getting hypo or hyperglycemia.
If a pump shuts down without warning and before the user expects it to, it could lead to the under-delivery of insulin. As the FDA explained in its recall, that could result in hyperglycemia and even diabetic ketoacidosis, a life-threatening complication caused by the inability of the body to turn sugar into energy due to the lack of insulin. Tandem Diabetes Care, the company behind the app and the pump, sent all affected customers an emergency notice back in March. It advised them to update their app, to monitor their pump battery level closely and to carry backup insulin supplies. The FDA’s recall notice could reach potentially affected customers who may not have seen the manufacturer’s alerts, however, or who may have brushed it aside. Malfunctioning insulin pumps had been linked to multiple deaths in the past, so users may want to keep a close eye on theirs regardless of the brand.
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