FDA recalls defective iOS app that injured over 200 insulin pump users

At slightest 224 group pinch glucosuria person reported injuries linked to a defective iOS app that caused their insulin pumps to unopen down prematurely, according to nan US Food and Drug Administration (FDA).

On Wednesday, nan agency announced that California-based aesculapian instrumentality shaper Tandem Diabetes Care has issued a callback for type 2.7 of nan iOS t:connect mobile app, which is utilized successful conjunction pinch nan company’s t:slim X2 insulin pump. Specifically, nan callback relates to a package rumor that tin origin nan app to many times clang and relaunch, resulting successful nan pump’s artillery being drained by excessive Bluetooth communication.

This artillery drain tin origin nan pump to unopen down “earlier than typically expected” according to Tandem, though nan pump will notify users of an imminent shutdown via an siren and low-power alert. The institution has notified customers to update nan mobile app to type 2.7.1 aliases later, which should hole nan defective software.

While nary beingness callback is taking place, nan FDA has identified this arsenic a “Class I” callback — nan astir superior type, arsenic it relates to issues pinch products that tin perchance origin superior injuries aliases death.

“Pump shutdown will origin insulin transportation to suspend, which could lead to an under-delivery of insulin and whitethorn consequence successful hyperglycemia, including terrible hyperglycemia,” Tandem warned successful its letter to customers successful March. “In terrible cases of hyperglycemia owed to a prolonged play of nary insulin delivery, nan personification whitethorn acquisition diabetic ketoacidosis and whitethorn require hospitalization aliases involution from a aesculapian professional.”

No deaths linked to nan issues person been reported arsenic of April 15th. Tandem is encouraging pump users to return peculiar attraction erstwhile they slumber arsenic it’s easier to miss artillery depletion warnings, and is asking impacted customers to corroborate they person been notified of nan callback via this online form. For immoderate different questions aliases concerns astir nan insulin pump recall, customers should interaction Tandem Diabetes Care directly.