BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENULTIMATE!

    MDR report key: 9372443 · Received November 25, 2019

    Report

    Report Number
    3008282042-2019-00005
    Event Type
    Malfunction
    Date Received
    November 25, 2019
    Date of Event
    April 9, 2018
    Report Date
    November 22, 2019
    Manufacturer
    PHARMA TECH SOLUTIONS, INC.
    Product Code
    NBW
    UDI-DI
    00868906000100
    PMA / PMN Number
    K103542
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    A CUSTOMER COMPLAINT PROMPTED AN INVESTIGATION BY OUR COMPANY INTO POTENTIAL PRODUCT MALFUNCTION. WE RAN 10 CONTROL TESTS ON THE CUSTOMER'S PRODUCT USING ONE TOUCH ULTRA CONTROL SOLUTION AND A ONE TOUCH ULTRA 2 METER. WE THEN CALCULATED THE MEAN OF THOSE RESULTS AND FOUND THEM TO BE OUT OF RANGE. WE THEN HAD RETAINS FROM THE SAME LOT OF PRODUCT TESTED BY A 3RD-PARTY (INITIAL REPORTER) AT A LOW GLUCOSE LEVEL AND A HIGH GLUCOSE LEVEL. THE STRIP READINGS WERE COMPARED TO THE GLUCOSE LEVELS, WHICH WERE MEASURED USING A YSI 2300 STAT PLUS GLUCOSE ANALYZER. BY THIS METHOD, IT WAS DETERMINED THAT THE RETAIN SAMPLE PRODUCT WAS GIVING FALSELY HIGH RESULTS AT BOTH THE LOW AND HIGH GLUCOSE LEVELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1163465 GENULTIMATE! BLOOD GLUCOSE TEST STRIPS NBW PHARMA TECH SOLUTIONS, INC. AF091 00868906000100

    Patients

    Seq Age Sex Outcome Treatment
    1