BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENULTIMATE TEST STRIPS

    MDR report key: 6650011 · Received June 15, 2017

    Report

    Report Number
    MW5070476
    Event Type
    Malfunction
    Date Received
    June 15, 2017
    Date of Event
    June 13, 2017
    Report Date
    June 15, 2017
    Manufacturer
    PHARMA TECH SOLUTIONS INC.
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    TEST STRIPS DO NOT WORK. FOLLOWED GLUCOSE TESTING PROCEDURE AND RECEIVED ERROR 5 MESSAGE: DEFECTIVE GLUCOSE TEST STRIP FOR 29/30 TESTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    426130 GENULTIMATE TEST STRIPS SYSTEM TEST, BLOOD GLUCOSE NBW PHARMA TECH SOLUTIONS INC. 7004A

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR