BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM G5 SYSTEM

    MDR report key: 10885844 · Received November 23, 2020

    Report

    Report Number
    3013756811-2020-130175
    Event Type
    Malfunction
    Date Received
    November 23, 2020
    Date of Event
    November 6, 2020
    Report Date
    November 23, 2020
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OYC
    UDI-DI
    00853052007295
    PMA / PMN Number
    P140015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PER TANDEM'S 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 INADVERTENTLY DELIVERED A 15 UNIT BOLUS. REPORTEDLY, THE CUSTOMER HAD ACCIDENTALLY ENTERED 330 GRAMS OF CARBOHYDRATES AND NO BLOOD GLUCOSE (BG) VALUE FOR BOLUS CALCULATION. THE CUSTOMER'S BG LEVEL RANGED FROM AROUND 142-284 MG/DL. CUSTOMER ACKNOWLEDGED THE ISSUE WAS DUE TO USER ERROR AND PUMP WAS PERFORMING AS INTENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1352111 T:SLIM G5 SYSTEM CONTINUOUS GLUCOSE MONITOR OYC TANDEM DIABETES CARE 1000096 00853052007295

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR