Over 200 diabetics suffered from injuries following a software glitch that emptied their insulin pump batteries.
The t:connect iOS app, used with the t:slim X2 insulin pump and Control-IQ, has experienced a software flaw that triggers it to crash and restart. Consequently, the device drains the pump's battery, which causes an early shutdown and suspension of insulin delivery.
This glitch could potentially result in hyperglycemia or even diabetic ketoacidosis, a severe condition characterized by high blood sugar levels and insufficient insulin, which can be fatal. According to the FDA, the issue has resulted in 224 reported injuries since April 15, but no deaths have been logged.
Tandem Diabetes Care Inc. distributed the faulty app from February 12 to March 13, and more than 85,000 users have been affected. The company has classified this as a Class I recall - the severest category of recall - due to the life-threatening nature of the issue.
On March 26, Tandem Diabetes Care mailed a device correction letter to impacted customers, advising them to upgrade the mobile app to version 2.7.1 or later. The company also urged users to keep monitoring their pumps, paying particular attention to system alerts as well as the battery level. It's crucial for them to ensure that the power is fully charged or nearly so before sleeping.
In the United States, customers can reach out to Tandem Diabetes Care's Technical Support Team at (877) 801-6901 for additional information.
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The t:connect app issue, causing the t:slim X2 insulin pump to drain batteries and halt insulin delivery, led to 224 reported injuries among diabetic users since April 15. Following the software glitch, diabetics were advised to upgrade the app to version 2.7.1 or later to prevent potential battery-related issues and subsequent complications.
Source: edition.cnn.com
