BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO PROVUE ANALYZER

    MDR report key: 725101 · Received June 9, 2006

    Report

    Report Number
    1056600-2006-00082
    Event Type
    Malfunction
    Date Received
    June 9, 2006
    Date of Event
    May 12, 2006
    Report Date
    June 7, 2006
    Manufacturer
    MICRO TYPING SYSTEMS, INC.
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER PERFORMED CROSSMATCH TESTING ON THE ORTHO PROVUE ANALYZER AND REPORTED THE ANALYZER INTERPRETED A WEAK POSITIVE REACTION AS NEGATIVE. THE COMPLAINT COULD NOT BE CONFIRMED WITH THE INFORMATION PROVIDED BY THE CUSTOMER. REPAIRS WERE NOT REQUIRED TO RETURN THE ANALYZER TO EXPECTED OPERATION. THE USER REPORTED THAT THE INCIDENT WAS ISOLATED AND DID NOT REQUEST SERVICE, AS THE ANALYZER WAS FUNCTIONING AS EXPECTED. IF A SIGNIFICANT ANTIBODY IS NOT DETECTED DURING CROSSMATCH TESTING, OR IS NOT IDENTIFIED UPON FURTHER TESTING, A PATIENT MAY BE TRANSFUSED WITH ANTIGEN-POSITIVE BLOOD AND SUFFER A HEMOLYTIC TRANSFUSION REACTION. OPTIMAL REACTION CONDITIONS MAY VARY DUE TO ANTIBODY SPECIFICITIES. NO SINGLE TEST METHOD WILL DETECT ALL ANTIBODIES. IN SOME LOW IONIC STRENGTH TEST SYSTEMS, CERTAIN ANTIBODIES HAVE BEEN REPORTED TO BE NONREACTIVE. BASED UPON AVAILABLE INFORMATION, PROVUE MALFUNCTION CANNOT BE RULED OUT. COMPLAINT # 718143 / Q 51317.

    Description of Event or Problem · 1

    THE CUSTOMER WAS PERFORMING CROSSMATCH TESTING ON THE ORTHO PROVUE ANALYZER AND REPORTED FALSE NEGATIVE REACTIVITY WITH ONE OF THREE DONORS TESTED.

    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 YR Other