BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO PROVUE

    MDR report key: 1052325 · Received May 23, 2008

    Report

    Report Number
    1056600-2008-00165
    Event Type
    Malfunction
    Date Received
    May 23, 2008
    Date of Event
    April 27, 2008
    Report Date
    May 23, 2008
    Manufacturer
    MICRO TYPING SYSTEMS, INC.
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    A POSSIBLE ROOT CAUSE WAS DETERMINED. AN OCD FIELD ENGINEER ARRIVED AT THE SITE AND DETERMINED THAT THE TUBING TO DILUTION CUP WAS DAMAGED. THE FE REPLACED THE TUBING TO RETURN THE INSTRUMENT TO EXPECTED OPERATION. THIS CUSTOMER HAS NOT LOGGED ANY SIMILAR COMPLAINTS AGAINST THIS ANALYZER SINCE THE REPAIR.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DILUTION CUP OVERFLOWED ON ORTHO PROVUE ANALYZER AND DROPLETS OF FLUID WAS OBSERVED ON TOP OF THE GEL CARD FOIL. 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