BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 10906614 · Received November 25, 2020

    Report

    Report Number
    3013756811-2020-137689
    Event Type
    Injury
    Date Received
    November 25, 2020
    Date of Event
    October 25, 2020
    Report Date
    November 25, 2020
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00850006613229
    PMA / PMN Number
    K201214
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 · 1

    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. REPORTEDLY, THE CUSTOMER EXPERIENCED AN ELEVATED BLOOD GLUCOSE (BG) READING RESULTING IN DIABETIC KETOACIDOSIS. REPORTEDLY, THE CUSTOMER ADMINISTERED A MANUAL INJECTION TO ADDRESS BG LEVEL. THE CUSTOMER WAS HOSPITALIZED AND TREATED WITH SALINE FLUIDS AND INSULIN FLUIDS. THE CUSTOMER ARRIVED AT THE HOSPITAL ON (B)(6) 2020 AND WAS RELEASED FROM THE HOSPITAL ON (B)(6) 2020. CUSTOMER SUSTAINED NO PERMANENT DAMAGE. TANDEM TECHNICAL SUPPORT ASSISTED CUSTOMER WITH STARTING CGM SESSION, LOADING NEW CARTRIDGE AND INFUSION SET TO RESUME INSULIN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1371411 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1002717 00850006613229

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| R