BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEM MOBI INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 23221586 · Received October 6, 2025

    Report

    Report Number
    3013756811-2025-230473
    Event Type
    Malfunction
    Date Received
    October 6, 2025
    Date of Event
    September 29, 2025
    Report Date
    December 3, 2025
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    PMA / PMN Number
    K233044
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS A DUPLICATE REPORT AND WAS FULLY REPORTED ON 3013756811-2025-232587.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE WAKE BUTTON WAS NOT WORKING. THERE WAS NO REPORTED ADVERSE EFFECT TO THE CUSTOMER'S BLOOD GLUCOSE LEVEL. REPORTEDLY, THE CUSTOMER REVERTED TO AN ALTERNATE METHOD OF INSULIN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2477923 TANDEM MOBI INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG TANDEM DIABETES CARE 1004000

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Unknown