BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GTI TEST KITS

    MDR report key: 1942098 · Received December 23, 2010

    Report

    Report Number
    MW5018711
    Event Type
    Malfunction
    Date Received
    December 23, 2010
    Date of Event
    December 17, 2010
    Report Date
    December 23, 2010
    Manufacturer
    GTI DIAGNOSTICS
    Product Code
    MYP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE GTI TEST KIT IS USED TO DETERMINE HIT ANTIBODIES. HOWEVER, IT HAS BEEN LEARNED THAT THE TEST KIT IS GIVING FALSE POSITIVES AS CONFIRMED BY THE BLOOD CTR OF (B)(6). GTI DOES NOT FEEL THIS IS CLINICALLY SIGNIFICANT AND RECOMMENDS IF THERE IS A QUESTION TO PURCHASE GTI'S CONFIRMATION KITS. HOWEVER, THE QUESTION THEN BECOMES WHAT DO YOU DO IF YOU GET WHAT YOU BELIEVE IS A FALSE POSITIVE, USE GTI'S CONFIRMATION KIT AND GET A NEGATIVE RESULT. THIS IS NOT A SATISFACTORY SOLUTION WHERE IT IS BELIEVED THERE IS A PRODUCT GIVING FALSE POSITIVES. OUR BLOOD BANK PHYSICIAN CAN PROVIDE MUCH MORE DETAILED INFO IF DESIRED. THE LOCAL SOLUTION IS THAT IF GTI'S TEST IS NEGATIVE, THEN NO FURTHER ACTION. IF THERE IS A POSITIVE TEST USING GTI'S KIT, ANOTHER SAMPLE WILL BE SENT TO THE BLOOD CTR OF (B)(6) FOR VERIFICATION. THIS IS NOT AN OPTIMAL SOLUTION BUT THE ONLY ONE WE FEEL COMFORTABLE WITH AT THE PRESENT TIME. DIAGNOSIS OR REASON FOR USE: HIT TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GTI TEST KITS GTI TEST KITS MYP GTI DIAGNOSTICS 031710-X45

    Patients

    Seq Age Sex Outcome Treatment
    1