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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 appsee related information
Date Initiated by FirmMarch 05, 2024
Date PostedMay 06, 2024
Recall Status1 Open3, Classified
Recall NumberZ-1609-2024
Recall Event ID 94312
510(K)NumberK203234 
Product Classification Alternate controller enabled insulin infusion pump - Product Code QFG
Productt: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 ContactMs. 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
ActionOn 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.
Quantity in Commerce85,863 applications
DistributionUS nationwide distribution including Puerto Rico.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = QFG
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