BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO PROVUE

    MDR report key: 1032014 · Received April 21, 2008

    Report

    Report Number
    1056600-2008-00126
    Event Type
    Malfunction
    Date Received
    April 21, 2008
    Date of Event
    March 27, 2008
    Report Date
    April 21, 2008
    Manufacturer
    MICRO TYPING SYSTEMS, INC.
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLES OR LOG FILES WERE NOT SUBMITTED TO OCD FOR ADD'L INVESTIGATION. THEREFORE, THE CUSTOMER'S COMPLAINT COULD NOT BE VERIFIED. SERVICE WAS NOT ORDERED ON THE PROVUE SINCE THE CUSTOMER HAD INDICATED THAT DAILY QC WAS ACCEPTABLE AND NO OTHER DISCREPANCIES WERE NOTED WITH OTHER PTS. INCIDENT WAS ISOLATED TO THE SAMPLE. DIFFERENCES OBSERVED BETWEEN TEST METHODS ARE NOT UNEXPECTED, SINCE THESE TEST METHODS MAY EXHIBIT DIFFERENT PATTERNS OF REACTIVITY AND SENSITIVITY DEPENDING ON THE SPECIFIC ANTIBODY. THIS CUSTOMER HAS NOT LOGGED ANY SIMILAR COMPLAINTS AGAINST THIS ANALYZER SINCE THE INCIDENT.

    Description of Event or Problem · 1

    THE CUSTOMER INDICATED THAT A SAMPLE PREVIOUSLY REPORTED AS GROUP O RH POSITIVE REACTED AS RH NEGATIVE ON THE ORTHO PROVUE ANALYZER. VISUAL INSPECTION OF THE PROCESSED GEL CARD CONFIRMED THE REACTIONS WERE NEGATIVE IN THE ANTI-D MICROTUBE OF THE GEL CARD. THE SAMPLE REACTED POSITIVE (4+) AT IMMEDIATE SPIN IN TUBE METHOD USING COMPETITOR'S ANTI-D ANTISERA. FALSE NEGATIVE TEST RESULTS CAN LEAD TO TRANSFUSION OF INCOMPATIBLE BLOOD. ERRONEOUS TEST RESULTS WERE NOT REPORTED, AS THE TEST RESULTS OBTAINED ON THE PROVUE DID NOT MATCH THE PT'S HISTORICAL DATA.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1