BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO PROVUE ANALYZER

    MDR report key: 768003 · Received November 14, 2005

    Report

    Report Number
    1056600-2005-00124
    Event Type
    Malfunction
    Date Received
    November 14, 2005
    Date of Event
    October 13, 2005
    Report Date
    November 10, 2005
    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

    THE CUSTOMER NOTICED THAT THE RED CELL BUTTON OF THE ANTI-LGG MICRO TUBE WAS SMALLER COMPARED TO PREVIOUS RESULTS. UPON INVESTIGATION, THE CUSTOMER NOTICED THAT THE ORTHO PROVUE ANALYZER HAD LEFT DROPLETS OF RED FLUID (RED CELLS) ON TOP OF THE FOIL OF THE MTS ANTI-LGG CARD. THE CUSTOMER DID NOT REPORT ANY ERROR MESSAGES GENERATED BY THE INSTRUMENT. NO ERRONEOUS RESULTS WERE REPORTED AS A RESULT OF THIS INCIDENT. ON 10/14/2005, AN OCD FIELD ENGINEER (FE) ARRIVED ON-SITE. THE FE REPAIRED THE INSTRUMENT AND PERFORMED THE NECESSARY ADJUSTMENTS. THE CUSTOMER VERIFIED QC. REPAIRS HAVE RETURNED THIS ANALYZER TO EXPECTED OPERATION. VACUUM OR PRESSURE LEAK CAN CAUSE OVER DISPENSE, UNDER DISPENSE OR PROBE LEAK. PROBE DRIP CAN LEAD TO EITHER WASH SOLUTION A OR B DRIPPING INTO A REAGENT VIAL. DILUTION OF THE REAGENT OR SAMPLE CAN COMPROMISE TEST REACTIONS. WASH SOLUTION A IS USED TO WASH AND RINSE THE INSIDE OF THE PROBE. WASH SOLUTION B IS USED TO WASH THE OUTSIDE OF THE PROBE. WASH SOLUTION B CONTAINS A DETERGENT, WHICH COULD ALSO HAVE A LYSING EFFECT, DESTROYING THE RED CELLS IN A REAGENT PRODUCT. FLUID ON TOP OF THE GEL CARD FOIL CAN ALSO LEAD TO CARRY OVER OR CROSS CONTAMINATION FROM MICRO TUBE TO MICRO TUBE. CARRY-OVER MAY CAUSE CROSS CONTAMINATION, WHICH CAN LEAD TO ERRONEOUS TEST RESULTS AND POSSIBLE TRANSFUSION OF INCOMPATIBLE BLOOD. IF THIS ISSUE WERE TO RECUR AND GO UNDETECTED, POSSIBLE ERRONEOUS RESULTS COULD OCCUR.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE ORTHO PROVUE ANALYZER HAD LEFT DROPLETS OF RED FLUID (RED CELLS) ON TOP OF THE FOIL OF THE MTS ANTI-LGG CARD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORTHO PROVUE ANALYZER AUTOMATED BLOOD GROUPING AND ANTIBODY TEST SYSTEM KSZ MICRO TYPING SYSTEMS, INC. MTS213784 *

    Patients

    Seq Age Sex Outcome Treatment
    1 Other