BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO PROVUE

    MDR report key: 1082503 · Received July 24, 2008

    Report

    Report Number
    1056600-2008-00242
    Event Type
    Malfunction
    Date Received
    July 24, 2008
    Date of Event
    July 1, 2008
    Report Date
    July 24, 2008
    Manufacturer
    MICRO TYPING SYSTEMS, INC.
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEFINITIVE ROOT CAUSE WAS DETERMINED. THE CUSTOMER INDICATED THAT THE "SPECKLING" REACTIONS OBSERVED WERE BELOW THE THRESHOLD OF THE GEL CAMERA. ALSO, THE ANALYZER INTERPRETED THE REACTIONS AS "?" UPON REPEAT TESTING, THEREFORE, SERVICE WAS NOT REQUIRED. SAMPLE VARIABILITY MAY HAVE CONTRIBUTED TO THIS INCIDENT. THIS CUSTOMER HAS NOT LOGGED ANY SIMILAR COMPLAINTS AGAINST THIS ANALYZER SINCE THIS INCIDENT. (B) (4)

    Description of Event or Problem · 1

    THE CUSTOMER INDICATED THAT A SAMPLE CONTAINING A POSITIVE ANTIBODY FAILED TO REACT ON THE ORTHO PROVUE ANALYZER. THE CUSTOMER DESCRIBED THE REACTION AS A "SPECKLE" IN THE MICROTUBE. THE SAMPLE REACTED WEAKLY POSITIVE (1+) IN MANUAL GEL TEST AT 30 MINUTES INCUBATION. THE SAMPLE WAS RETESTED ON THE PROVUE AND THE RESULT WAS INTERPRETED AS "?", (WITH MORE "SPECKLING") USING A DIFFERENT LOT OF REAGENT CELLS. ANTI-E WAS IDENTIFIED. 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