BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO PROVUE

    MDR report key: 1021626 · Received March 27, 2008

    Report

    Report Number
    1056600-2008-00096
    Event Type
    Malfunction
    Date Received
    March 27, 2008
    Date of Event
    February 27, 2008
    Report Date
    March 26, 2008
    Manufacturer
    MICRO TYPING SYSTEMS, INC.
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEFINITIVE CAUSE WAS DETERMINED. THIS CUSTOMER HAS NOT LOGGED ANY COMPLAINTS AGAINST THIS ANALYZER SINCE THIS INCIDENT. ADD'L INVESTIGATION IS BEING PERFORMED ON THE GEL CARD SINCE THE CARD COULD NOT BE RULED OUT AS A CONTRIBUTING FACTOR.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE ORTHO PROVUE ANALYZER INTERPRETED A POSITIVE REACTION AS NEGATIVE DURING DAT TESTING USING MTS ANTI-IGG-C3D CARD LOT# 050207005-04. THE REACTIONS IN THE AFFECTED MICROTUBES WERE VISUALLY CONFIRMED TO BE 1+. THE CUSTOMER PERFORMED ADD'L TESTING USING MTS ANTI-IGG CARD (LOT # NOT PROVIDED) AND ALSO IN TUBE METHOD USING ANTI-C3D TUBE REAGENT AND OBTAINED NEGATIVE RESULTS. INFO WAS NOT PROVIDED WHETHER TESTING WITH THE MTS ANTI-IGG CARD WAS PERFORMED IN MANUAL GEL OR ON THE PROVUE. 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 SYSTEM KSZ MICRO TYPING SYSTEMS, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1