BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO ANTIBODY TO HBSAG ELISA TEST SYSTEM 2

    MDR report key: 466825 · Received May 30, 2003

    Report

    Report Number
    2250051-2003-00820
    Event Type
    Malfunction
    Date Received
    May 30, 2003
    Date of Event
    February 20, 2003
    Report Date
    May 28, 2003
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    LOM
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING A FRESH SERUM STUDY ONE DONOR SAMPLE TESTED NEGATIVE USING ORTHO HBSAG SYSTEM 2 ELISA. THIS SAMPLE TESTED POSITIVE USING THE ORTHO HBGAG SYSTEM 3 ELISA AND WAS POSITIVE UPON RETEST THE ORTHO HBSAG SYSTEM 2 ELISA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORTHO ANTIBODY TO HBSAG ELISA TEST SYSTEM 2 IN-VITRO DIAGNOSTIC ELISA LOM ORTHO-CLINICAL DIAGNOSTICS 931570 2HB560

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other