BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO PROVUE

    MDR report key: 1040634 · Received May 8, 2008

    Report

    Report Number
    1056600-2008-00148
    Event Type
    Malfunction
    Date Received
    May 8, 2008
    Date of Event
    April 13, 2008
    Report Date
    May 8, 2008
    Manufacturer
    MICRO TYPING SYSTEMS, INC.
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEFINITIVE ROOT CAUSE WAS DETERMINED. AN OCD FIELD ENGINEER VISITED THE CUSTOMER SITE AND OBSERVED EVIDENCE OF LEAKAGE AT THE VACUUM CONNECTOR TO THE PROBE WASH STATION. REPLACEMENT OF THE APPROPRIATE COMPONENTS HAS RETURNED THE INSTRUMENT TO EXPECTED OPERATION. THIS CUSTOMER HAS NOT LOGGED ANY SIMILAR COMPLAINTS AGAINST THIS ANALYZER SINCE THIS INCIDENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY OBSERVED SPLASHES OF FLUID ON TOP OF GEL CARDS AND INCUBATOR SLOTS WHILE PERFORMING QC TESTING ON THE ORTHO PROVUE ANALYZER. TESTING WAS ABORTED, NO ERRONEOUS RESULTS WERE REPORTED. FLUID ON TOP OF THE GEL CARD FOIL CAN LEAD TO CARRY OVER, AND/OR CROSS CONTAMINATION, WHICH CAN LEAD TO ERRONEOUS TEST RESULTS AND 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