More than 200 people with diabetes were injured after technology defect caused their insulin pump to unexpectedly shut down, according to the Food and Drug Administration.
The software glitch has prompted the recall of more than 85,000 versions of a mobile app, called t:connect and developed by Tandem Diabetes Care, the FDA noted on Wednesday.
The Apple iOS-based software recall involves Version 2.7 of the mobile app, which works with the t:slim X2 insulin pump with Control-IQ technology. The issue can cause the app to continuously crash and restart, draining the pump's battery.
A shutdown of the pump suspends the delivery of insulin, which can result in hyperglycemia or even ketoacidosis, a potentially life-threatening condition that can require hospitalization or intervention by a medical professional. Tandem urged patients and physicians who use the device to update the app to version 2.7.1 or later as soon as possible.
As of April 15, there have been 224 reported injuries and no reports of death, according to the notice posted by the FDA.
Roughly 38 million people in the U.S. have diabetes, according to the Centers for Disease Control and Prevention. Diabetes can cause health complications including blindness, kidney failure, heart disease, stroke, and loss of toes, feet or legs.
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