BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO PROVUE

    MDR report key: 1521748 · Received November 2, 2009

    Report

    Report Number
    1056600-2009-00235
    Event Type
    Malfunction
    Date Received
    November 2, 2009
    Date of Event
    September 19, 2009
    Report Date
    November 2, 2009
    Manufacturer
    MICRO TYPING SYSTEMS, INC.
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IF THE ANTI-M WAS LGM IN NATURE IT WOULD NOT HAVE BEEN DETECTED WITH THE MTS ANTI-LGG GEL CARDS ON THE PROVUE, WHICH MAY EXPLAIN THE NEGATIVE ANTIBODY SCREEN. THIS CUSTOMER HAS NOT LOGGED ANY COMPLAINTS AGAINST THIS ANALYZER SINCE THIS INCIDENT. (B) (4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE ORTHO PROVUE RESULTED A SAMPLE CONTAINING ANTI-M AS FALSE NEGATIVE WHEN PERFORMING AN ANTIBODY SCREEN TEST. THE SAMPLE WAS SENT TO A REFERENCE LAB WHICH IDENTIFIED THE ANTI-M USING THE TUBE METHOD WITH PEG AND INDICATED THAT THE ANTIBODY WAS TOO WEAK TO TITER. NO ERRONEOUS RESULTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORTHO PROVUE AUTOMATED BLOOD GROUPING & ANTIBODY TEST SYST KSZ MICRO TYPING SYSTEMS, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1