BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 18502169 · Received January 12, 2024

    Report

    Report Number
    3013756811-2024-06877
    Event Type
    Injury
    Date Received
    January 12, 2024
    Date of Event
    December 24, 2023
    Report Date
    January 12, 2024
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00389152000107
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    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 CUSTOMER ALLOWED THE PUMP BATTERY TO FULLY DEPLETE DUE TO NOT CHARGING THE BATTERY AND THE PUMP SUBSEQUENTLY SHUT OFF. CUSTOMER'S BLOOD GLUCOSE (BG) WAS LOW, HOWEVER, A SPECIFIC VALUE WAS NOT PROVIDED. CUSTOMER CONSUMED CARBOHYDRATES TO ADDRESS BG LEVEL. REPORTEDLY THE CUSTOMER CONTINUED TO USE THE PUMP FOR INSULIN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2058966 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1000354 00389152000107

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female