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t:connect Mobile Application (Android) 1004127Recalls & reported problems

Tandem Diabetes Care, Inc. · t:connect Mobile Application (Android) · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00850006613267), received between Oct 5, 2021 and Oct 5, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Compatibility Problem” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Compatibility Problem1
  • Device Alarm System1
  • Product Quality Problem1
  • Use of Device Problem1

Patient problems

  • Insufficient Information1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionOct 5, 2021Device Alarm System; Product Quality Problem; Use of Device Problem; Compatibility Problem

    THE PRODUCT IN QUESTION THE TANDEM DIABETES T:CONNECT (B)(6) APP - (B)(6) APP FOR THE T:SLIM X2 SERIES OF INSULIN PUMPS. THE APP IS CONSIDERED A MEDICAL DEVICE AND HAS GONE THROUGH FDA APPROVAL. THERE ARE A FEW PROBLEMS I BELIEVE BAD ENOUGH TO WARRANT REMOVAL OF THE APP, THE MOST DANGEROUS OF WHICH HAS BEEN PRESENT FOR OVER A YEAR (BASED ON APP REVIEWS AND COMMENTS ONLINE). THIS ISN'T A COMPATIBILITY OR CONFIGURATION ISSUE - MY PHONE IS CONFIGURED CORRECTLY AND IS "SUPPORTED." THE APP RANDOMLY LOGS YOU OUT OF YOUR ACCOUNT, AND REQUIRES YOU TO LOG BACK IN SEVERAL TIMES A DAY. THERE IS NO WARNING NOR INDICATION THAT ANYTHING IS AMIS. AS FAR AS I CAN TELL, THE APP CEASES TO FUNCTION ENTIRELY WHEN NOT LOGGED IN, MEANING ALERTS WILL NOT SOUND. OBVIOUSLY IT ALSO INTERRUPTS PROVIDER DATA UPLOAD. I HAVE TO LOG IN AT LEAST TWICE A DAY, USUALLY CLOSER TO FOUR OR FIVE TIMES. TANDEM IS AWARE AND CLAIMS TO BE WORKING ON IT. I BELIEVE THE APP'S APPROVAL SHOULD BE REVOKED AND IT REMOVED FROM THE PLAY STORE UNTIL THIS IS FIXED. IT PURPORTS TO PROVIDE ALERTS YOU CAN TRUST THAT YOU CANNOT GET FROM OTHER APPS (SUCH AS PREDICTED FUTURE HYPO EVENTS). THE APP DOES NOT REMAIN RUNNING IN THE BACKGROUND DE

    Patient problems: Insufficient Information

    MAUDE report 12583658 ↗

Other Continuous Glucose Monitor Secondary Display devices

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.