BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEM MOBI INSULIN PUMP WITH CONTROL-IQ+ TECHNOLOGY

    MDR report key: 24208848 · Received January 29, 2026

    Report

    Report Number
    3013756811-2026-17761
    Event Type
    Malfunction
    Date Received
    January 29, 2026
    Date of Event
    January 25, 2026
    Report Date
    January 29, 2026
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00389152481319
    PMA / PMN Number
    K240309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ADDED A141204.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BATTERY GAUGE WAS FLUCTUATING RESULTING IN THE PUMP SHUTTING DOWN. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE VALUE. THE CUSTOMER CONTINUED TO USE THE PUMP FOR INSULIN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    275301 TANDEM MOBI INSULIN PUMP WITH CONTROL-IQ+ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG TANDEM DIABETES CARE 1004000 00389152481319

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Female