BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTICS PRODUCTS AHAV IGM REAGENT PACK

    MDR report key: 1026515 · Received April 3, 2008

    Report

    Report Number
    9680658-2008-00091
    Event Type
    Malfunction
    Date Received
    April 3, 2008
    Date of Event
    February 29, 2008
    Report Date
    March 6, 2008
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    CFQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INTO THIS EVENT FOUND THAT THE REACTIVE RESULTS OCCURRED WITH TWO DIFFERENT VITROS AHAV IGM REAGENT LOTS AND ON TWO DIFFERENT VITROS ECI SYSTEMS. THE ROOT CAUSE OF THE REACTIVE RESULTS COULD NOT BE DETERMINED, HOWEVER, THE PT'S CONDITION AND OTHER TEST RESULTS INDICATE THAT THE TRUE CLASSIFICATION OF THE SAMPLE IS AHAV IGM NEGATIVE. WHILE THE CAUSE IS UNK, IT IS NOT DUE TO THE ANALYZER, WHICH PERFORMED ACCEPTABLY, BUT MIGHT BE DUE TO A SAMPLE INTERFERENT.

    Description of Event or Problem · 1

    A CUSTOMER OBSERVED FALSELY REACTIVE AHAV IGM RESULTS FROM A SINGLE PT TESTED ON THE VITROS ECI ANALYZER. THE RESULTS DID NOT AGREE WITH RESULTS GENERATED ON A COMPETITIVE METHOD. QUALITY CONTROL RESULTS WERE WITHIN ACCEPTABLE RANGES. ERRONEOUS ANTI-HAV IGM RESULTS MAY LEAD TO CONFUSION IN THE DIAGNOSIS AND TREATMENT OF ACUTE HEPATITIS. THE REACTIVE VITROS RESULT WAS REPORTED, HOWEVER, THERE WAS NO ALLEGATION OF HARM AS A RESULT OF THIS EVENT. NOTE: THERE ARE TWO CONSECUTIVELY NUMBERED FORM 3500A BEING FILED FOR THIS EVENT. THE FALSELY REACTIVE AHAV IGM RESULTS WERE OBTAINED ON TWO DIFFERENT AHAV IGM REAGENT LOTS (LOT 1110, MDR #9680658-2008-00091 AND LOT 1160, MDR #9680658-2008-00092).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITROS IMMUNODIAGNOSTICS PRODUCTS AHAV IGM REAGENT PACK IN-VITRO DIAGNOSTIC CFQ ORTHO-CLINICAL DIAGNOSTICS NA 1110

    Patients

    Seq Age Sex Outcome Treatment
    1