FDA: Recalled Insulin Pump App Caused Hospitalizations, Adverse Injuries

Published on August 13, 2024

A pharmaceutical company said Monday that its recalled iOS app and insulin pump has led to several hospitalizations and more than 107 confirmed adverse events, adding that consumers have continued to experience issues after an update. Tandem Diabetes Care, the company, rolled out an update in March to fix the problem with its Apple iOS t:connect mobile app but said in its Monday alert that customers have continued to report problems. The app is used with the t:slim X2 insulin pump with Control-IQ. “This battery depletion can result in the pump shutting down sooner than expected, which some customers have continued to experience following the release of version 2.7.1 of the app in March,” Tandem Diabetes said in its notice, posted on the FDA’s website....

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