BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:FLEX INSULIN DELIVERY SYSTEM

    MDR report key: 10084118 · Received May 22, 2020

    Report

    Report Number
    3013756811-2020-52602
    Event Type
    Malfunction
    Date Received
    May 22, 2020
    Date of Event
    April 30, 2020
    Report Date
    May 22, 2020
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    UDI-DI
    00852162004385
    PMA / PMN Number
    K143189
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CARTRIDGE ALARM 19 INTERMITTENTLY OCCURRED DURING BASAL DELIVERY WITH MULTIPLE CARTRIDGES. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 130-140 MG/DL. REPORTEDLY, THE CUSTOMER CONTINUED TO USE THE PUMP FOR INSULIN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    546427 T:FLEX INSULIN DELIVERY SYSTEM INFUSION PUMP LZG TANDEM DIABETES CARE 004628-005 00852162004385

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR INSULIN: NOVOLOG / NOVORAPID