t:connect mobile app used in conjunction with t:slim X2 insulin pump with Control-IQ technology

FDA device recall Z-1609-2024 · posted 2024-05-06 · Open, Classified

Recall details

Recalling firm

Tandem Diabetes Care, Inc.

Reason for recall

During normal use, the mobile app version 2.7 may crash and be automatically relaunched by the iOS operating system. This cycle intermittently repeats, which leads to excessive Bluetooth communication that may result in pump battery drain and may lead to the pump shutting down sooner than typically expected. Pump shutdown will cause insulin delivery to suspend, which could lead to an under-delivery of insulin and may result in hyperglycemia, including severe hyperglycemia.

Action taken

On 10/09/2024, Tandem send via email an "URGENT MEDICAL DEVICE CORRECTION UPDATE" informing customers of additional actions required (uninstall and reinstall mobile app version 2.8.2) to address the faster than expected battery depletion issue. Customers are instructed to: 1.Touch and hold the app icon. 2.Tap Remove App, then tap Delete App to confirm. 3.Go to Apple App Store. 4.Search t:connect mobile to locate the t:connect mobile app. 5.Tap Download, or the cloud icon with an arrow. 6.Login with your t:connect account credentials and re-pair with your Tandem t:slim X2 pump. For complete re-pair instructions, please visit our website here. Between the dates of August 9-12, 2024, Tandem issued a Press Release and sent an "URGENT MEDICAL DEVICE CORRECTION UPDATE" Letter due to becoming aware that users may still be experiencing pump battery depletion after updating the mobile app to version 2.7.1. On August 19, 2024, Tandem issued a press release announcing the future release of the next version of the t:connect mobile app version 2.8.2. On August 20, 2024, Tandem sent a follow-up email and in-app push notification to all affected users who Tandem has a valid email announcing the release of T:connect mobile app version 2.8.2. - The customer email communication will include a URL and QR code to provide a method for users to acknowledge receipt. Between the dates of August 21, 2024 - September 4, 2024, Tandem will send an "Urgent Medical Device Correction Update" to all affected app users via First-Class Postal mail. This notification will outline the release of T:connect mobile app version 2.8.2.

Root cause

Software Design Change

Status

Open, Classified

Product code

QFG

Quantity affected

85,863 applications

Distribution

US nationwide distribution including Puerto Rico.

Date initiated

2024-03-05

Date posted

2024-05-06

Location

San Diego, CA

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