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The U.S. Food and Drug Administration has issued a Class I "most serious type of recall" for an iOS app used in conjunction with an insulin pump.
The "correction" as referred to by the FDA on Wednesday, rather than a product removal, relates to the t:connect Mobile App iOS v2.7. It was confirmed by Tandem Diabetes Care the following day, which stated that Android app users are not included in the recall.
"The t:connect mobile app works with the t:slim X2 insulin pump with Control-IQ technology," the FDA states. The pump delivers insulin under the skin at set and variable rates for the management of diabetes.
The app recall is due to a software issue that may cause the app to crash and be automatically relaunched which "may result in pump battery drain and may lead to the pump shutting down sooner than typically expected."
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In this photo illustration, a young woman with type-1 diabetes sits outside in front of purple bougainvillea flowers while holding her insulin pump and smartphone. (Photo Illustration by Matt Harbicht/Getty Images for Tandem Diabetes Care / Getty Images)
| Ticker | Security | Last | Change | Change % |
|---|---|---|---|---|
| TNDM | TANDEM DIABETES CARE INC | 32.51 | +1.88 | +6.14% |
The FDA says pump shutdown "could lead to an under-delivery of insulin and may result in hyperglycemia or even diabetic ketoacidosis, which can be a life-threatening condition due to high blood sugars and lack of insulin," and encourages those with diabetes who use insulin pumps to carry backup supplies in case of pump failure.
"The correction highlighted in the recall notice was addressed in the t:connect app update for the Apple iOS platform (v2.7.1) released on March 18th," Tandem Diabetes Care said in a press release. "Affected customers were notified by Tandem on March 26th, and more than 98% of affected customers had already updated their devices as of April 15th. We continue to make every effort to contact everyone who has not yet updated their iOS app to the new version."
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In this photo illustration, a man looks at his supplies for type-1 diabetes management, including tubed insulin pump, insulin vial, syringe, needle, insulin cartridge, and infusion site applicator. (Photo Illustration by Matt Harbicht/Getty Images for Tandem Diabetes Care / Getty Images)
Tandem Diabetes Care gives detailed instructions to customers who wish to check their mobile app versions here.
As of April 15, 224 injuries have been reported.
In this photo illustration, a woman taps the screen of her diabetes management app as she views her blood glucose levels. (Photo Illustration by Matt Harbicht/Getty Images for Tandem Diabetes Care / Getty Images)
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"Ensuring the safety of our patients is our top priority, and we take any safety concerns with our products very seriously," Tandem Diabetes Care said in its release. "No deaths have been reported, and we will continue monitoring the new version of the t:connect app released in March to ensure the concerns described in the recent recall notice from the FDA have been addressed."