BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 15123699 · Received July 28, 2022

    Report

    Report Number
    3013756811-2022-79964
    Event Type
    Injury
    Date Received
    July 28, 2022
    Date of Event
    July 7, 2022
    Report Date
    July 7, 2022
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00850006613762
    PMA / PMN Number
    K201214
    Adverse Event
    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. THE PUMP USER GUIDE STATES, "TANDEM DIABETES CARE, INC. RECOMMENDS PERIODICALLY CHECKING THE BATTERY LEVEL INDICATOR, CHARGING THE PUMP FOR A SHORT PERIOD OF TIME EVERY DAY (10 TO 15 MINUTES), AND ALSO AVOIDING FREQUENT FULL DISCHARGES."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CUSTOMER ALLOWED THE PUMP BATTERY TO FULLY DEPLETE DUE TO NOT CHARGING THE BATTERY AND THE PUMP SUBSEQUENTLY SHUT OFF. THE CUSTOMER'S BLOOD GLUCOSE (BG) LEVEL WAS 120 - 560 MG/DL. REPORTEDLY, THE CUSTOMER ADMINISTERED A CORRECTION BOLUS VIA PUMP AND CHANGED THE INFUSION SET TO ADDRESS ELEVATED BG LEVEL AND CONTINUED TO USE THE PUMP FOR INSULIN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2940761 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 71 YR Male Other INSULIN: HUMALOG