BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    MDR report key: 9873531 · Received March 24, 2020

    Report

    Report Number
    3013756811-2020-30083
    Event Type
    Injury
    Date Received
    March 24, 2020
    Date of Event
    March 3, 2020
    Report Date
    March 24, 2020
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OZO
    UDI-DI
    00853052007325
    PMA / PMN Number
    P180008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    "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 · 1

    IT WAS REPORTED THAT THE CUSTOMER WENT TO THE EMERGENCY ROOM, AND WAS SUBSEQUENTLY HOSPITALIZED DUE TO AN ELEVATED BLOOD GLUCOSE LEVEL OF 700 MG/DL AND DIABETIC KETOACIDOSIS. A CHEST X-RAY AND ELECTROCARDIOGRAM TEST WERE DONE. CUSTOMER WAS TREATED WITH AN INTRAVENOUS INSULIN AND FLUID DRIP, AND WAS RELEASED FROM THE HOSPITAL 4 DAYS LATER WITH NO PERMANENT DAMAGE. REPORTEDLY, THE PUMP SHUTDOWN DUE TO NORMAL BATTERY DEPLETION DUE TO THE CUSTOMER NOT CHARGING THE PUMP. THE CUSTOMER WAS UNAWARE THAT THE CARTRIDGE NEEDED TO BE RELOADED IN ORDER TO RESUME INSULIN THERAPY. TANDEM TECHNICAL SUPPORT EDUCATED THE CUSTOMER ON HOW TO PROPERLY RESUME INSULIN THERAPY. CTS VERIFIED THE PUMP FUNCTIONED AS INTENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336271 T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND OZO TANDEM DIABETES CARE 1000096 00853052007325

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Hospitalization| R INSULIN: HUMALOG