BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 14917356 · Received July 5, 2022

    Report

    Report Number
    3013756811-2022-71056
    Event Type
    Malfunction
    Date Received
    July 5, 2022
    Date of Event
    June 5, 2022
    Report Date
    June 22, 2022
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00850006613762
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    NO PRODUCT WAS RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A CARTRIDGE ALARM 16 OCCURRED. CUSTOMER¿S BLOOD GLUCOSE VALUE WAS 100 - 250 MG/DL. REPORTEDLY, A NEW CARTRIDGE WAS SUCCESSFULLY LOADED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376709 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1002717 00850006613762

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Male