BEUDAMED
    FDA Adverse Event Other Summary report: N

    ORTHO PROVUE

    MDR report key: 1080976 · Received July 24, 2008

    Report

    Report Number
    1056600-2008-00240
    Event Type
    Other
    Date Received
    July 24, 2008
    Date of Event
    June 27, 2008
    Report Date
    July 24, 2008
    Manufacturer
    MICRO TYPING SYSTEMS, INC.
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    A POSSIBLE ROOT CAUSE WAS DETERMINED. THE CONNECTIONS FROM THE WASH SOLUTION A AND B WERE SWITCHED, RESULTING IN CONTAMINATION AND POSSIBLY THE FALSE POSITIVE RESULTS. THE CUSTOMER CONNECTED THE LINES APPROPRIATELY TO RETURN THE INSTRUMENT TO EXPECTED OPERATION. INCIDENT OCCURRED AS A USER ERROR. INSTRUMENT MALFUNCTION WAS NOT IDENTIFIED. THE CUSTOMER HAS NOT LOGGED ANY COMPLAINTS AGAINST THIS INSTRUMENT SINCE THIS INCIDENT. INCIDENT IS ISOLATED. (B) (4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY OBSERVED FALSE POSITIVE REACTIONS IN THE MTS GEL CARDS WHILE PERFORMING QC TESTING ON THE ORTHO PROVUE ANALYZER. NO ERRONEOUS RESULTS WERE REPORTED. IT WAS DETERMINED THAT AN INCORRECT WASH SOLUTION WAS USED. AN INCORRECT WASH SOLUTION USED DURING TESTING MAY CAUSE CARRY-OVER, CROSS CONTAMINATION OR HEMOLYSIS OF REAGENTS OR SAMPLES, WHICH COULD RESULT IN ERRONEOUS TEST RESULTS.

    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

    Patients

    Seq Age Sex Outcome Treatment
    1