BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADVIA CENTAUR XP HBSAG ASSAY

    MDR report key: 1864902 · Received October 4, 2010

    Report

    Report Number
    1219913-2010-00113
    Event Type
    Other
    Date Received
    October 4, 2010
    Date of Event
    September 4, 2010
    Report Date
    September 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

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE DISCORDANT (B)(6) RESULT IS UNK. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A (B)(6) RESULT WAS OBTAINED FOR A PT SAMPLE. THE CUSTOMER RAN THE PT SAMPLE AS PART OF A CORRELATION STUDY AND THE RESULT WAS (B)(6). A CORRECTED REPORT WAS ISSUED TO THE PHYSICIAN. PT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE (B)(6) RESULT.

    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 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1