BEUDAMED
    FDA Adverse Event Other Summary report: N

    AXSYM HBSAG

    MDR report key: 2982442 · Received September 19, 2007

    Report

    Report Number
    1415939-2007-00224
    Event Type
    Other
    Date Received
    September 19, 2007
    Date of Event
    April 17, 2007
    Report Date
    May 2, 2007
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    KSJ
    PMA / PMN Number
    P050049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS IS AN INITIAL REPORT. AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT DISCREPANT (B)(6) RESULTS WERE GENERATED ON A PREGNANT PATIENT. ON (B)(6) 2007, TESTING WAS REPEATEDLY (B)(6) AND CONFIRMED (B)(6) USING THE AXSYM HBSAG CONFIRMATORY ASSAY. ON (B)(6) 2007, INITIAL TESTING WAS (B)(6) AND REPEAT TESTING WAS NONREACTIVE (B)(6). NO CONFIRMATORY TESTING WAS PERFORMED. ON (B)(6) 2007, TESTING WAS REPEATEDLY (B)(6) AND CONFIRMED (B)(6) USING THE AXSYM HBSAG CONFIRMATORY ASSAY. ADDITIONAL (B)(6) TESTING ON (B)(6) 2007 WAS CONFIRMED (B)(6). THE SAMPLE FROM (B)(6) 2007 WAS SENT OUT FOR (B)(6) TESTING (METHOD NOT SPECIFIED) WHICH WAS (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AXSYM HBSAG MEIA FOR THE QUALITATIVE DETECTION OF HEPATITIS B SURFACE ANTIGEN KSJ ABBOTT LABORATORIES NA 49492M200

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR AXSYM ANALYZER LIST 7A83-95, SERIAL (B)(4)