BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 12859776 · Received November 23, 2021

    Report

    Report Number
    3013756811-2021-131091
    Event Type
    Injury
    Date Received
    November 23, 2021
    Date of Event
    November 15, 2021
    Report Date
    November 23, 2021
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00850006613793
    PMA / PMN Number
    K201214
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    NO PRODUCT WAS RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. H6: REMOVE 2995, 61 ADD 1383, 1503, 67.

    Additional Manufacturer Narrative · 0

    ROOT CAUSE: USE ERROR/TRAINING. 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. 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 THE BATTERY GAUGE WAS FLUCTUATING RESULTING IN THE PUMP SHUTTING DOWN. CUSTOMER'S BLOOD GLUCOSE WAS IN 360-HIGH MG/DL RANGE. ELEVATED BLOOD GLUCOSE WAS ADDRESS WITH MANUAL INJECTION. CUSTOMER CONTINUED TO USE THE PUMP FOR INSULIN THERAPY.

    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. CUSTOMER'S BLOOD GLUCOSE WAS IN 360-HIGH MG/DL RANGE. ELEVATED BLOOD GLUCOSE WAS ADDRESS WITH MANUAL INJECTION. CUSTOMER CONTINUED TO USE THE PUMP FOR INSULIN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1759888 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1000354 00850006613793

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Female Other