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FDA recalls defective iOS app that injured over 200 insulin pump users

Tandem Diabetes Care hasn’t reported any deaths linked to the issue.

On Wednesday, the agency announced that California-based medical device manufacturer Tandem Diabetes Care has issued a recall for version 2.7 of the iOS t:connect mobile app, which is used in conjunction with the company’s t:slim X2 insulin pump. “In severe cases of hyperglycemia due to a prolonged period of no insulin delivery, the user may experience diabetic ketoacidosis and may require hospitalization or intervention from a medical professional.” Tandem is encouraging pump users to take particular care when they sleep as it’s easier to miss battery depletion warnings, and is asking impacted customers to confirm they have been notified of the recall via this online form.

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