BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO PROVUE

    MDR report key: 1221523 · Received November 5, 2008

    Report

    Report Number
    1056600-2008-00330
    Event Type
    Malfunction
    Date Received
    November 5, 2008
    Date of Event
    October 17, 2008
    Report Date
    November 5, 2008
    Manufacturer
    MICRO TYPING SYSTEMS, INC.
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    AN OCD FIELD ENGINEER VISITED THE SITE AND VERIFIED THE PRESSURE, VACUUM, CENTRIFUGE PERFORMANCE AND OPTIMIZED THE PROVUE. THE FE VERIFIED REPAIRS BY PERFORMING QC TESTING. QC PASSED. THIS CUSTOMER HAS NOT LOGGED ANY COMPLAINTS AGAINST THIS ANALYZER SINCE THIS INCIDENT. CUSTOMER COMPLAINT WAS NOT CONFIRMED USING THE RETURNED SAMPLE. THE RESULTS OBTAINED WITH MANUAL GEL TEST WERE CONCORDANT WITH THE PROVUE TEST RESULTS AT OCD USING THE RETURNED SAMPLE AND THE SAME LOT OF RED CELL REAGENTS USED BY THE CUSTOMER. THE CUSTOMER INDICATED THAT CELL #S 2 AND 10 REACTED AS WEAK 1+ WITH THE SAMPLE USING 0.8% PANEL A LOT VRA121. HOWEVER, THE SAMPLE CREATED NEGATIVE IN MANUAL GEL AND ALSO ON THE PROVUE WITH LOT VRA121 (CELL #S 2 AND 10) AT OCD.

    Description of Event or Problem · 1

    THE CUSTOMER INDICATED THAT THE ORTHO PROVUE ANALYZER INTERPRETED A WEAKLY POSITIVE TEST REACTION AS NEGATIVE. 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