BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTICS PRODUCTS ANTI-HIV 1 + 2 REAGENT PACK

    MDR report key: 1161467 · Received September 11, 2008

    Report

    Report Number
    9680658-2008-00270
    Event Type
    Malfunction
    Date Received
    September 11, 2008
    Date of Event
    August 12, 2008
    Report Date
    August 13, 2008
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    MTL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INTO THIS EVENT SHOWED THAT THE FALSE POSITIVE RESULTS WERE RELATED TO MULTIPLE SAMPLES FROM A SINGLE PATIENT. ANALYSIS OF INSTRUMENT DATALOGGER FILES FOUND NO EVIDENCE TO SUGGEST THE RESULTS IN QUESTION WERE CAUSED BY AN ANALYZER, OR REAGENT MALFUNCTION. TESTING WITH HETEROPHILE ANTIBODY BLOCKING TUBES RULED OUT HETEROPHILIC ANTIBODY INTERFERENCE. THE INVESTIGATION WAS UNABLE TO DETERMINE A DEFINITIVE ROOT CAUSE, HOWEVER, AN UNKNOWN INTERFERENT (OTHER THAN HETEROPHILIC ANTIBODIES) CANNOT BE RULED OUT.

    Description of Event or Problem · 1

    A CUSTOMER OBSERVED REPEATABLE, FALSE POSITIVE ANTI-HIVE (VITROS AHIV 1 + 2 ASSAY) RESULTS FOR MULTIPLE SAMPLES OBTAINED FROM ONE PATIENT TESTED ON A VITROS ECI ANALYZER. THE RESULTS DID NOT AGREE WITH RESULTS FROM AN ALTERNATE AHIV ASSAY AND WESTERN BLOT TESTING ON THE SAME SAMPLES. THE FALSE POSITIVE RESULT WAS REPORTED, AND THE PATIENT WAS TREATED. THERE WERE NO ALLEGATIONS OF HARM AS A RESULT OF THE TREATMENT GIVEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITROS IMMUNODIAGNOSTICS PRODUCTS ANTI-HIV 1 + 2 REAGENT PACK IN VITRO DIAGNOSTIC MTL ORTHO-CLINICAL DIAGNOSTICS NA 0040

    Patients

    Seq Age Sex Outcome Treatment
    1