BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP

    MDR report key: 9177357 · Received October 10, 2019

    Report

    Report Number
    3013756811-2019-65044
    Event Type
    Malfunction
    Date Received
    October 10, 2019
    Date of Event
    September 17, 2019
    Report Date
    October 10, 2019
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    UDI-DI
    00852162004781
    PMA / PMN Number
    K111210
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT MULTIPLE MALFUNCTION ALARMS OCCURRED INTERMITTENTLY. CUSTOMER'S BLOOD GLUCOSE LEVEL RANGED FROM 240-248 MG/DL. REPORTEDLY, THE CUSTOMER WILL CONTINUE TO USE THE PUMP FOR INSULIN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    969143 T:SLIM X2 INSULIN PUMP INSULIN PUMP LZG TANDEM DIABETES CARE 1000096 00852162004781

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR