BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO PROVUE

    MDR report key: 1230494 · Received November 7, 2008

    Report

    Report Number
    1056600-2008-00340
    Event Type
    Malfunction
    Date Received
    November 7, 2008
    Date of Event
    October 8, 2008
    Report Date
    November 7, 2008
    Manufacturer
    MICRO TYPING SYSTEMS, INC.
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN OCD FIELD ENGINEER VISITED THE SITE, CLEANED THE CAMERA LENS AND DIFFUSER PLATE AND MADE ADJUSTMENTS TO THE READER CAMERA BRIGHTNESS TO IT'S OPTIMAL SETTING. THE FE ALSO CREATED A NEW REFERENCE IMAGE AND PERFORMED WAD DIAGNOSTICS TESTING WITHOUT ANY ISSUES. THIS CUSTOMER HAS NOT LOGGED ANY COMPLAINTS AGAINST THIS ANALYZER SINCE THIS INCIDENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT IN 2008, THE ORTHO PROVUE ANALYZER INTERPRETED A PATIENT'S SAMPLE AS ANTIBODY SCREEN NEGATIVE. NO ERRONEOUS RESULTS WERE REPORTED. FALSE NEGATIVE TEST RESULTS CAN LEAD TO TRANSFUSION OF INCOMPATIBLE BLOOD.

    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