BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 9242360 · Received October 25, 2019

    Report

    Report Number
    3013756811-2019-72428
    Event Type
    Malfunction
    Date Received
    October 25, 2019
    Date of Event
    October 9, 2019
    Report Date
    October 25, 2019
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    UDI-DI
    00852162004361
    PMA / PMN Number
    K111210
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT MULTIPLE MALFUNCTION ALARMS OCCURRED INTERMITTENTLY. THE CUSTOMER REVERTED TO AN ALTERNATE METHOD OF INSULIN THERAPY. CUSTOMER¿S BLOOD GLUCOSE VALUE RANGED FROM 150-395 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1031795 T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE 004628 00852162004361

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR