BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 11930960 · Received June 3, 2021

    Report

    Report Number
    3013756811-2021-58703
    Event Type
    Injury
    Date Received
    June 3, 2021
    Date of Event
    May 10, 2021
    Report Date
    June 3, 2021
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00850006613762
    PMA / PMN Number
    K201214
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 · 1

    IT WAS REPORTED THAT THE PUMP SHUTDOWN DUE TO NORMAL BATTERY DEPLETION; BLOOD GLUCOSE (BG) LEVEL WAS 369 MG/DL. CUSTOMER SUBSEQUENTLY WENT TO THE EMERGENCY ROOM. A CORRECTION BOLUS VIA THE PUMP, AND INTRAVENOUS SALINE AND INSULIN WERE ADMINISTERED TO ADDRESS BG. CUSTOMER WAS RELEASED FROM THE ER APPROXIMATELY 3 HOURS LATER. A PUMP SYSTEM CHECK CONFIRMED PUMP WAS FUNCTIONING PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    831222 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 59 YR Required Intervention INSULIN: HUMALOGINFUSION SET PRODUCT: AUTOSOFT XC