BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP

    MDR report key: 9083212 · Received September 18, 2019

    Report

    Report Number
    3013756811-2019-60772
    Event Type
    Malfunction
    Date Received
    September 18, 2019
    Date of Event
    August 23, 2019
    Report Date
    September 18, 2019
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    UDI-DI
    00852162004798
    PMA / PMN Number
    K111210
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT INTERMITTENT CARTRIDGE ALARMS OCCURRED (ALARM 19) DURING THE LOAD SEQUENCE WITH MULTIPLE CARTRIDGES. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 220-240 MG/DL. REPORTEDLY, THE CUSTOMER REVERTED TO MANUAL INJECTIONS FOR INSULIN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    878389 T:SLIM X2 INSULIN PUMP INSULIN PUMP LZG TANDEM DIABETES CARE 1000096 00852162004798

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR