BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO PROVUE ANALYZER

    MDR report key: 729965 · Received June 20, 2005

    Report

    Report Number
    1056600-2005-00058
    Event Type
    Malfunction
    Date Received
    June 20, 2005
    Date of Event
    May 19, 2005
    Report Date
    June 17, 2005
    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

    CUSTOMER STATES THAT A KNOWN ANTI-E WAS READ AS NEGATIVE BY THE ORTHO PROVUE, BUT UPON VISUAL INSPECTION, THE RESULT WAS POSITIVE. THE CUSTOMER REPEATED TESTING IN MANUAL GEL CONFIRMING THE WEAK POSITIVE REACTIVITY. PROVUE MALFUNCTION CANNOT BE RULED OUT. IF A SIGNIFICANT ANTIBODY IS NOT DETECTED DURING ANTIBODY SCREENING, OR IS NOT IDENTIFIED UPON FURTHER TESTING, A PT MAY BE TRANSFUSED WITH ANTIGEN-POSITIVE BLOOD AND SUFFER A HEMOLYTIC TRANSFUSION REACTION. OPTIMAL REACTION CONDITIONS MAY VARY DUE TO ANTIBODY SPECIFICITIES. NO SINGLE TES METHOD WILL DETECT ALL ANTIBODIES. IN SOME LOW IONIC STRENGTH TEST SYSTEMS, CERTAIN ANTIBODIES SUCH AS ANTI-E AND ANTI-K, HAVE BEEN REPORTED TO BE NONREACTIVE. BASED UPON THE AVAILABLE INFORMATION. PROVUE MALFUNCTION CANNOT BE RULED OUT.

    Description of Event or Problem · 1

    CUSTOMER STATES THAT A KNOWN ANTI-E WAS READ AS NEGATIVE BY THE ORTHO PROVUE, BUT UPON VISUAL INSPECTION, THE RESULT WAS POSITIVE. REPEAT TESTING IN MANUAL GEL CONFIRMED A WEEK POSITIVE REACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORTHO PROVUE ANALYZER AUTOMATED BLOOD GROUPING AND ANTIBODY TEST SYSTEM KSZ MICRO TYPING SYSTEMS, INC. MTS213784 *

    Patients

    Seq Age Sex Outcome Treatment
    1 Other