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U.S. Department of Health and Human Services

Class 1 Device Recall t:connect mobile app

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  Class 1 Device Recall t:connect mobile app see related information
Date Initiated by Firm March 05, 2024
Date Posted May 06, 2024
Recall Status1 Open3, Classified
Recall Number Z-1609-2024
Recall Event ID 94312
510(K)Number K203234  
Product Classification Alternate controller enabled insulin infusion pump - Product Code QFG
Product t:connect mobile app used in conjunction with t:slim X2 insulin pump with Control-IQ technology
Code Information version 2.7 or later /UDI: 00850006613274
Recalling Firm/
Manufacturer		 Tandem Diabetes Care, Inc.
11075 Roselle St
San Diego CA 92121-1204
For Additional Information Contact Ms. Susan Morrison
877-801-6901
Manufacturer 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.
FDA Determined
Cause 2		 Software Design Change
Action On March 26, 2024 Tandem Diabetes Care issued an Urgent Medical Device Correction via E-Mail to affected consignees 1. On March 18, 2024, Tandem released a new version of the mobile app, t:connect mobile app version 2.7.1, to address the issue. 2. Please update your mobile app to version 2.7.1 or later, available in the Apple App Store, to access quality improvements. 3. If your mobile app has been updated to version 2.7.1 or later, there is no update action required. To identify the software version of the t:connect mobile app, open the app, click the Setting icon on your iPhone's screen, and then click About. 4. It is important to acknowledge receipt of this notice by completing the online form available at the following link or by using the QR code below. Even if you do not plan on updating your mobile app to version 2.7.1 or later, Tandem requests that you still complete the online form or by using the QR code. www.tandemdiabetes.com/battery-depletion. 5. Continue using your Tandem pump as described in the User Guide. 6. Pay attention to all system alerts and alarms. 7. Please monitor your pump battery level closely to ensure the pump is at or near full charge before going to sleep to help prevent pump shutdown. 8. Always carry back-up supplies. 9. To avoid pump shut down, if battery life is depleted more quickly than you are used to, Tandem strongly recommends you begin charging you device after the first low battery alert.
Quantity in Commerce 85,863 applications
Distribution US nationwide distribution including Puerto Rico.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = QFG and Original Applicant = Tandem Diabetes Care, Inc.
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