FDA issues ‘most serious type of recall’ involving app-reliant insulin pumps
(NewsNation) — The U.S. Food and Drug Administration has issued a recall correction for an Apple iOS app used with an insulin pump that has caused at least 224 injuries after draining the pump’s battery and causing it to shut off early.
Tandem Diabetes Care, Inc. is recalling version 2.7 of the t:connect mobile app that pairs with the t:slim X2 insulin pump with Control IQ technology.
“The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death,” the agency said in a statement.
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The software may cause the app to crash and automatically relaunch intermittently, which leads to excessive Bluetooth communication that may drain the pump’s battery sooner than expected, according to the FDA’s notice.
When the pump shuts down, it stops insulin delivery. That could lead to hyperglycemia or diabetic ketoacidosis, a potentially life-threatening condition caused by high blood sugar and lack of insulin.
Impacted users and health care providers should update the app to version 2.7.1 or later and closely monitor their pump battery level.
The FDA recommends that people with diabetes always carry backup supplies for insulin delivery in case of pump failure.
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