BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENULTIMATE!

    MDR report key: 9862935 · Received March 20, 2020

    Report

    Report Number
    3007197758-2020-00001
    Event Type
    Malfunction
    Date Received
    March 20, 2020
    Date of Event
    March 16, 2020
    Report Date
    March 20, 2020
    Manufacturer
    PHARMA TECH SOLUTIONS, INC.
    Product Code
    NBW
    UDI-DI
    00868906000100
    PMA / PMN Number
    K103542
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    A CUSTOMER COMPLAINT PROMPTED AN INVESTIGATION BY OUR COMPANY INTO A POTENTIAL PRODUCT MALFUNCTION. WE HAD THE CUSTOMER'S PRODUCT TESTED BY A 3RD-PARTY (INITIAL REPORTER) WITH WHOLE BLOOD 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 CUSTOMER'S PRODUCT WAS GIVING FALSELY HIGH RESULTS AT THE LOW GLUCOSE LEVEL, WHILE THE HIGH GLUCOSE LEVEL RESULTS WERE WITHIN ACCEPTABLE LIMITS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    326741 GENULTIMATE! BLOOD GLUCOSE TEST STRIPS NBW PHARMA TECH SOLUTIONS, INC. 100-50 9008A 00868906000100

    Patients

    Seq Age Sex Outcome Treatment
    1