BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADVIA CENTAUR XP HBSAG ASSAY

    MDR report key: 1707048 · Received May 28, 2010

    Report

    Report Number
    1219913-2010-00061
    Event Type
    Other
    Date Received
    May 28, 2010
    Date of Event
    April 25, 2010
    Report Date
    May 11, 2010
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    LOM
    PMA / PMN Number
    P030049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE DISCORDANT (B)(6) RESULT IS UNKNOWN. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED. ADD'L LOT #: 144. ADDITIONAL EXPIRATION DATE: 05/30/2010.

    Description of Event or Problem · 1

    (B)(6) ADVIA CENTAUR XP (B)(6) RESULTS WERE OBTAINED FOR A PATIENT SAMPLE FOR SEVERAL DATES. ONE SAMPLE WAS TESTED USING THE ADVIA CENTAUR CONFIRMATORY ASSAY AND THE RESULTS WERE RESOLUTE AND INVALID. THE CUSTOMER TESTED FOR (B)(6) AND THE RESULT WAS NEGATIVE. PATIENT 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 XP HBSAG ASSAY HBS IMMUNOASSAY LOM SIEMENS HEALTHCARE DIAGNOSTICS INC. NA 142,

    Patients

    Seq Age Sex Outcome Treatment
    1