Over 200 individuals with diabetes sustained injuries when a malfunction in technology caused their insulin pump to unexpectedly shut down, as reported by the Food and Drug Administration.
The recall of more than 85,000 units of a mobile app, known as t:connect and created by Tandem Diabetes Care, was initiated due to a software glitch, as noted by the FDA on Wednesday.
The software recall, based on Apple iOS, pertains to Version 2.7 of the mobile app, designed to function with the t:slim X2 insulin pump featuring Control-IQ technology. The problem can lead to the app continuously crashing and restarting, depleting the pump's battery.
A shutdown of the pump halts the insulin delivery, potentially causing hyperglycemia or ketoacidosis, a critical condition that may necessitate hospitalization or medical intervention. Tandem urged individuals and healthcare providers utilizing the device to promptly update the app to version 2.7.1 or later.
An estimated 38 million individuals in the United States are living with diabetes, as reported by the Centers for Disease Control and Prevention. Diabetes is a condition that can lead to various health complications such as blindness, kidney failure, heart disease, stroke, and even the amputation of toes, feet, or legs.
