BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEM MOBI MOBILE APP

    MDR report key: 23851098 · Received December 19, 2025

    Report

    Report Number
    3013756811-2025-284092
    Event Type
    Malfunction
    Date Received
    December 19, 2025
    Date of Event
    December 14, 2025
    Report Date
    December 19, 2025
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    PMA / PMN Number
    K233044
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    A CUSTOMER REPORTED THAT THE MOBILE APPLICATION FROZE WHILE THEY WERE DELIVERING A BOLUS USING AN ANDROID PHONE. THERE WAS NO REPORTED ADVERSE IMPACT. AFTER THE INCIDENT, THE CUSTOMER FOLLOWED TECHNICAL SUPPORT'S ADVICE TO CHECK AND ADJUST THE DEVELOPER OPTIONS SETTINGS ON THEIR PHONE. THE APPLICATION WAS SUCCESSFULLY RE-LAUNCHED, AND NO ADDITIONAL ASSISTANCE WAS NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258009 TANDEM MOBI MOBILE APP ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG TANDEM DIABETES CARE

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Male