BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 10630074 · Received October 5, 2020

    Report

    Report Number
    3013756811-2020-105505
    Event Type
    Injury
    Date Received
    October 5, 2020
    Date of Event
    September 12, 2020
    Report Date
    October 5, 2020
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00850006613229
    PMA / PMN Number
    K201214
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PER TANDEM'S PUMP USER GUIDE, "DO NOT DELIVER A BOLUS UNTIL YOU HAVE REVIEWED THE CALCULATED BOLUS AMOUNT ON THE PUMP DISPLAY. IF YOU DOSE AN INSULIN AMOUNT THAT IS TOO HIGH OR TOO LOW, THIS COULD CAUSE VERY HIGH OR VERY LOW BLOOD GLUCOSE. YOU CAN ALWAYS ADJUST THE INSULIN UNITS UP OR DOWN BEFORE YOU DECIDE TO DELIVER YOUR BOLUS." 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 ADMINISTERED A MANUAL INJECTION TO ADDRESS A BLOOD GLUCOSE (BG) LEVEL. REPORTEDLY, THE CUSTOMER¿S BG DID NOT LOWER PRIOR TO THE PUMP DELIVERING AN AUTOMATIC BOLUS AS INTENDED. SUBSEQUENTLY, THE CUSTOMER¿S BG LOWERED TO 33MG/DL. THE CUSTOMER CONSUMED CARBOHYDRATES AND GLUCOSE TABLETS. PARAMEDICS WERE CALLED, HOWEVER, NO ASSISTANCE WAS PROVIDED AS CUSTOMER¿S BG HAD INCREASED PRIOR TO THE PARAMEDICS ARRIVING. RECOMMENDATION WAS MADE TO CONSULT WITH HEALTH CARE PROVIDER REGARDING DIABETES MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1095993 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 73 YR Required Intervention