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Tandem Diabetes Care begins updated software rollout after recall

August 20, 2024 By Sean Whooley

Tandem Diabetes Care tslim_X2_Insulin_Pump_Front_View_Control-IQ_RGB
Image from Tandem Diabetes

Tandem Diabetes Care (Nasdaq:TNDM) announced today that it released version 2.8.2 of its Apple iOS t:connect mobile app in the U.S.

The company initiated the new software release to remedy issues with prior versions of the technology. Its t:connect mobile app works in conjunction with the t:slim X2 automated insulin pump with Control-IQ technology. Tandem encourages all impacted iOS users to update their mobile app as soon as the app becomes available in the Apple App Store.

In March, the San Diego-based company initiated a recall of Version 2.7 of the Apple iOS t:connect mobile app. Tandem recalled the software version because of an issue that may cause the mobile app to crash and be automatically relaunched by the iOS operating system.

This cycle intermittently repeats, which leads to excessive Bluetooth communication, according to Tandem. That may result in pump battery drain, potentially leading to the pump shutting down sooner than typically expected. Pump shutdown could cause insulin delivery to suspend, which may lead to an under-delivery of insulin. That, in turn, could result in hyperglycemia or diabetic ketoacidosis, a potentially life-threatening condition due to high blood sugars and lack of insulin.

Recently, Tandem communicated that users of the initial update to Version 2.7 (V2.7.1) continued to experience these issues. The company issued updated information to impacted customers on Aug. 9 and provided recommendations for avoiding battery depletion.

In total, Tandem reports 143 confirmed adverse events related to the recall, including two hospitalizations and zero deaths.

Filed Under: Business/Financial News, Diabetes, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Recalls, Regulatory/Compliance, Technology Tagged With: Tandem Diabetes Care

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About Sean Whooley

Sean Whooley is an associate editor who mainly produces work for MassDevice, Medical Design & Outsourcing and Drug Delivery Business News. He received a bachelor's degree in multiplatform journalism from the University of Maryland, College Park. You can connect with him on LinkedIn or email him at swhooley@wtwhmedia.com.

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