BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO PROVUE

    MDR report key: 1022686 · Received April 1, 2008

    Report

    Report Number
    1056600-2008-00102
    Event Type
    Malfunction
    Date Received
    April 1, 2008
    Date of Event
    March 11, 2008
    Report Date
    April 1, 2008
    Manufacturer
    MICRO TYPING SYSTEMS, INC.
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEFINITIVE CAUSE WAS DETERMINED. AN OCD FIELD ENGINEER ARRIVED AT THE CUSTOMER SITE AND VERIFIED ALIGNMENTS AND ADJUSTMENTS TO THE CAMERA AND REPLACED ADD'L COMPONENTS TO RETURN THE INSTRUMENT TO EXPECTED OPERATION. THIS CUSTOMER HAS NOT LOGGED ANY COMPLAINTS AGAINST THIS ANALYZER SINCE THIS INCIDENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE ORTHO-PROVUE ANALYZER RESULTED IN A FALSE NEGATIVE. THE VISUAL INSPECTION OF THE PROCESSED GEL CARD SHOWED THE REACTION WAS NEGATIVE. WITH MANUAL TESTING THE RESULT WAS FOUND TO BE POSITIVE. ERRONEOUS TEST RESULTS WERE NOT 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 SYSTEM KSZ MICRO TYPING SYSTEMS, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1