BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORHTO PROVUE ANALYZER

    MDR report key: 789106 · Received November 22, 2006

    Report

    Report Number
    1056600-2006-00339
    Event Type
    Malfunction
    Date Received
    November 22, 2006
    Date of Event
    October 25, 2006
    Report Date
    November 22, 2006
    Manufacturer
    MICRO TYPING SYSTEMS, INC.
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER WAS PERFORMING ANTIBODY SCREEN TESTING ON THE ORTHO PROVUE ANALYZER AND REPORTED THAT A WEAKLY POSITIVE REACTION WAS INTERPRETED AS NEGATIVE. AN OCD FIELD ENGINEER (FE) ARRIVED ON SITE. THE FE PERFORMED REPAIRS AND THE APPROPRIATE ADJUSTMENTS TO RETURN THE ANALYZER TO EXPECTED OPERATION. NO DEATH OR SERIOUS INJURY WAS REPORTED AS A RESULT OF THIS INCIDENT. NO ERRONEOUS RESULTS WERE REPORTED. IF A SIGNIFICANT ANTIBODY IS NOT DETECTED DURING ANTIBODY SCREENING, OR IT IS NOT IDENTIFIED UPON FURTHER TESTING, A PT MAY BE TRANSFUSED WITH ANTIGEN-POSITIVE BLOOD AND SUFFER A HEMOLYTIC TRANSFUSION REACTION. BASED UPON THE AVAILABLE INFO, PROVUE MALFUNCTION CANNOT BE RULED OUT. STN# BK030023.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A FALSE NEGATIVE ANTIBODY SCREEN WAS OBTAINED WITH A QC SAMPLE ON THE ORTHO PROVUE ANALYZER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORHTO PROVUE ANALYZER AUTOMATED BLOOD GROUPING AND ANTIBODY TE KSZ MICRO TYPING SYSTEMS, INC. MTS213784 2.15

    Patients

    Seq Age Sex Outcome Treatment
    1 *