BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO PROVUE

    MDR report key: 1111612 · Received August 13, 2008

    Report

    Report Number
    1056600-2008-00256
    Event Type
    Malfunction
    Date Received
    August 13, 2008
    Date of Event
    July 11, 2008
    Report Date
    August 13, 2008
    Manufacturer
    MICRO TYPING SYSTEMS, INC.
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEFINITIVE ROOT CAUSE WAS DETERMINED FOR THE FALSE NEGATIVE RESULTS REPORTED BY THE CUSTOMER. THE CUSTOMER INDICATED THAT THE ANTI-C PRESENT IN THE PT'S PLASMA WAS A VERY LOW TITER AND WAS CONFIDENT THAT THE PROVUE WAS OPERATING AS EXPECTED. THEREFORE, SVC WAS NOT SCHEDULED. THE CUSTOMER INDICATED THAT THE ISSUE WAS RELATED TO THE PT SAMPLES. NO OTHER DISCREPANCIES HAD BEEN OBSERVED WITH OTHER PT SAMPLES OR WITH QC. INCIDENT WAS ISOLATED. THIS CUSTOMER HAS NOT LOGGED ANY COMPLAINTS AGAINST THIS ANALYZER SINCE THIS INCIDENT.

    Description of Event or Problem · 1

    IN 2008, THE CUSTOMER REPORTED THAT THE ORTHO PROVUE ANALYZER RESULTED A PT'S SAMPLE AS NEGATIVE ON THE ORTHO PROVUE ANALYZER. ANTI-C ANTIBODY WAS IDENTIFIED IN MANUAL GEL TEST. THE CUSTOMER TESTED THE SAMPLE USING TRADITIONAL TUBE METHOD WITH LIS AND PEG AS AN ENHANCEMENT AND OBTAINED NEGATIVE RESULTS WITH SCREENING CELLS. THE PT HAD NO PREVIOUS HISTORY. THE PT WAS READMITTED THE NEXT DAY, AND A SAMPLE WAS TESTED ON THE PROVUE USING THE SAME LOTS OF REAGENTS AND GEL CARD LOT#S AND NEGATIVE REACTIONS WERE OBTAINED. 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