BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:FLEX INSULIN DELIVERY SYSTEM

    MDR report key: 9306180 · Received November 11, 2019

    Report

    Report Number
    3013756811-2019-76819
    Event Type
    Malfunction
    Date Received
    November 11, 2019
    Date of Event
    June 1, 2019
    Report Date
    November 11, 2019
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    UDI-DI
    00852162004385
    PMA / PMN Number
    K143189
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP BATTERY INTERMITTENTLY COULD NOT BE CHARGED. CUSTOMER¿S BLOOD GLUCOSE LEVEL RANGED FROM 150-250 MG/DL. THE CUSTOMER CONTINUED TO USE THE PUMP FOR INSULIN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1101570 T:FLEX INSULIN DELIVERY SYSTEM INFUSION PUMP LZG TANDEM DIABETES CARE 004628-005 00852162004385

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR