BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 22494506 · Received July 14, 2025

    Report

    Report Number
    3013756811-2025-166450
    Event Type
    Malfunction
    Date Received
    July 14, 2025
    Date of Event
    July 6, 2025
    Report Date
    July 14, 2025
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00389152000077
    PMA / PMN Number
    K203234
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    A CARTRIDGE CHANGE ERROR WAS REPORTED WITH THE PUMP. THE CUSTOMER'S BLOOD GLUCOSE LEVEL DID NOT EXCEED 500 MG/DL (27.7 MMOL/L), SO THERE WAS NO ADVERSE IMPACT. TECHNICAL SUPPORT INSTRUCTED THE CUSTOMER TO INSPECT AND CLEAN THE PUMP'S COMPONENTS, RESULTING IN THE SUCCESSFUL LOADING OF THE CARTRIDGE AND RESUMPTION OF INSULIN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    809344 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG TANDEM DIABETES CARE 1002717 00389152000077

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male