BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO PROVUE

    MDR report key: 1052334 · Received May 23, 2008

    Report

    Report Number
    1056600-2008-00172
    Event Type
    Malfunction
    Date Received
    May 23, 2008
    Date of Event
    April 29, 2008
    Report Date
    May 23, 2008
    Manufacturer
    MICRO TYPING SYSTEMS, INC.
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    A POSSIBLE ROOT CAUSE WAS DETERMINED. AN OCD FIELD ENGINEER VISITED THE CUSTOMER SITE AND DETERMINED THAT THE PT'S SAMPLE CONTAINED FIBRIN, WHICH RESULTED IN THE FALSE POSITIVE REACTION REPORTED BY THE CUSTOMER. THE FE VERIFIED THAT THE INSTRUMENT WAS OPERATING AS EXPECTED. INSTRUMENT MALFUNCTION WAS NOT IDENTIFIED. THEREFORE, SERVICE WAS NOT REQUIRED. THIS CUSTOMER HAS NOT LOGGED ANY COMPLAINTS AGAINST THIS ANALYZER SINCE THIS INCIDENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A PATIENT'S SAMPLE REACTED FALSE POSITIVE (MIXED FIELD) IN THE ANTI-D MICROTUBE OF THE MTS GEL CARD ON THE ORTHO PROVUE ANALYZER. THE CUSTOMER REPEATED THE SAMPLE IN MANUAL GEL TEST USING THE SAME LOT OF GEL CARDS AND OBTAINED NEGATIVE REACTIVITY IN THE ANTI-D MICROTUBE. REPEAT TESTING ON THE PROVUE GAVE A 2+ REACTION IN THE ANTI-D MICROTUBE. NO ERRONEOUS RESULTS WERE REPORTED. FALSE POSITIVE TEST RESULTS COULD 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 Other