FDA issues recall for diabetes app after over 200 reported injuries

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FDA issues recall for diabetes app after over 200 reported injuries
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Andrew Paul is Popular Science‘s staff writer covering tech news. Previously, he was a regular contributor to The A.V. Club and Input, and has had recent work featured by Rolling Stone, Fangoria, GQ, Slate, NBC, as well as McSweeney’s Internet Tendency. He lives outside Indianapolis.

The US Food and Drug Administration issued a software recall after a defective diabetes management iPhone app reportedly shut off insulin pumps, injuring at least 224 users. Initially approved by the FDA in February 2022, Tandem Medical Care’s t:connect iOS app was the first of its kind to receive regulatory approval. Once downloaded, t:connect works alongside Tandem’s t:slim X2 insulin pump by allowing diabetes patients to issue bolus doses of insulin over Bluetooth.

The software patch was also announced at the same time. The FDA announced the new Class I recall, its “most serious” type, on Wednesday for version 2.7 of the t:connect iOS app. They also warned that continued use “may cause serious injuries or death,” although no deaths have so far been reported due to the issue. Tandem has already contacted customers and released an over-the-air 2.7.1 patch that “should fix the defective software.

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