BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADVIA CENTAUR HBSAG ASSAY

    MDR report key: 1791953 · Received August 4, 2010

    Report

    Report Number
    1219913-2010-00088
    Event Type
    Other
    Date Received
    August 4, 2010
    Date of Event
    July 6, 2010
    Report Date
    July 13, 2010
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    LOM
    PMA / PMN Number
    P030049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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.

    Description of Event or Problem · 1

    A (B)(6) RESULT WAS OBTAINED FOR A PATIENT SAMPLE. THE (B)(6) RESULT DID NOT MATCH THE RESULTS OF THE OTHER (B)(6) MEASURED. THE PATIENT SAMPLE WAS TESTED AGAIN AND THE RESULTS WERE 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 HBSAG ASSAY HBS IMMUNOASSAY LOM SIEMENS HEALTHCARE DIAGNOSTICS INC. NA 149

    Patients

    Seq Age Sex Outcome Treatment
    1