BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADVIA CENTAUR HBSAG ASSAY

    MDR report key: 1692202 · Received May 13, 2010

    Report

    Report Number
    1219913-2010-00053
    Event Type
    Other
    Date Received
    May 13, 2010
    Date of Event
    April 27, 2010
    Report Date
    May 1, 2010
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    LOM
    PMA / PMN Number
    P030049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE DISCORDANT (B)(6) RESULT IS UNK. A SIEMENS REP EXAMINED THE (B)(6) QC AND CALIBRATIONS. NO ISSUES WERE FOUND. THE INSTRUMENT IS PERFORMING WITHIN SPECS. NO FURTHER EVAL OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A POSITIVE ADVIA CENTAUR (B)(6) RESULT WAS OBTAINED FOR A PT SAMPLE AND CONFIRMED USING THE ADVIA CENTAUR CONFIRMATORY ASSAY. THE PHYSICIAN QUESTIONED THE RESULTS. ANOTHER SAMPLE THAT WAS RECEIVED THAT SAME DAY FROM THE SAME PT WAS TESTED. THE RESULTS WERE REACTIVE FOR (B)(6) BUT DID NOT CONFIRM WITH THE CONFIRMATORY ASSAY. THE PTS LIVER ENZYMES WERE ALL NORMAL. PT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT (B)(6) RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA CENTAUR HBSAG ASSAY HBS IMMUNOASSAY LOM SIEMENS HEALTHCARE DIAGNOSTICS INC. NA 148

    Patients

    Seq Age Sex Outcome Treatment
    1