BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADVIA CENTAUR XP HBSAG AND HCV ASSAY

    MDR report key: 1582909 · Received January 19, 2010

    Report

    Report Number
    1219913-2010-00006
    Event Type
    Other
    Date Received
    January 19, 2010
    Date of Event
    July 1, 2009
    Report Date
    January 8, 2010
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC
    Product Code
    LOM
    PMA / PMN Number
    P030049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS REP REVIEWED THE ACCOUNT'S HISTORY AND NO HARDWARE ISSUES WERE FOUND IN THE TIME FRAME OF THE DISCORDANT RESULTS. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. THE CAUSE OF THE DISCORDANT (B)(6) AND (B)(6) RESULTS IS UNK. NO FURTHER EVAL OF THE DEVICE IS REQUIRED. (B)(4). ADDITIONAL CATALOG # 03438099.

    Description of Event or Problem · 1

    POSITIVE ADVIA CENTAUR XP (B)(6) AND (B)(6) RESULTS WERE OBTAINED ON TWO SEPARATE PT SAMPLES AND THE RESULTS WERE REPORTED TO THE PHYSICIAN IN (B)(6) OF 2009. THE PTS HAD A REDRAW SEVERAL MONTHS LATER AND WERE TESTED FOR (B)(6) (PT 1) AND (B)(6) (PT 2). THE RESULTS WERE NON-REACTIVE. THE PHYSICIAN QUESTIONED THE ORIGINAL RESULTS. THE PT SAMPLES HAVE BEEN DISCARDED AND NO FURTHER TESTING WAS PERFORMED. IT IS UNK IF PT TREATMENT WAS PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT (B)(6) AND (B)(6) RESULTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1