BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 12814460 · Received November 15, 2021

    Report

    Report Number
    3013756811-2021-121508
    Event Type
    Malfunction
    Date Received
    November 15, 2021
    Date of Event
    October 27, 2021
    Report Date
    November 15, 2021
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00850006613793
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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 180-228 MG/DL. REPORTEDLY, A NEW CARTRIDGE WAS SUCCESSFULLY LOADED AFTER THE PUMP WAS RESET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1709060 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1000354 W0102427 00850006613793

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Female INSULIN: HUMALOG