BEUDAMED
    FDA Adverse Event Summary report: N

    ADVIA CENTAUR XP HBSAG ASSAY

    MDR report key: 2070245 · Received April 27, 2011

    Report

    Report Number
    1219913-2011-00061
    Date Received
    April 27, 2011
    Date of Event
    March 29, 2011
    Report Date
    April 13, 2011
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    LOM
    PMA / PMN Number
    P030049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE DISCORDANT HBSAG RESULT IS UNKNOWN. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. THE CUSTOMER DECLINED SERVICE - NO FURTHER ACTION TAKEN. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A FALSE (B)(6) ADVIA CENTAUR XP HBSAG RESULT WAS OBTAINED FOR A PATIENT SAMPLE. THE PATIENT WAS REDRAWN AND TESTED. THE RESULT WAS (B)(6) AND CONFIRMED AS (B)(6). PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT HBSAG RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA CENTAUR XP HBSAG ASSAY HBS IMMUNOASSAY LOM SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 153

    Patients

    Seq Age Sex Outcome Treatment
    1