BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADVIA CENTAUR HBSAG ASSAY

    MDR report key: 1616627 · Received February 22, 2010

    Report

    Report Number
    1219913-2010-00025
    Event Type
    Other
    Date Received
    February 22, 2010
    Date of Event
    February 12, 2010
    Report Date
    February 15, 2010
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    LOM
    PMA / PMN Number
    P030029
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: THE CUSTOMER SENT THE PATIENT SAMPLE TO SIEMENS HEALTHCARE DIAGNOSTICS FOR FURTHER TESTING. THE PATIENT SAMPLE WAS TESTED ON THE ADVIA CENTAUR HBSAG AND THE RESULT WAS POSITIVE. THE SAMPLE IS NEUTRALIZED AT 95.8% WITH THE CONFIRMATORY ASSAY. THE CONCLUSION IS, THERE IS HBSAG IN THE RETURNED SPECIMEN. THIS IS CONCORDANT WITH THE CUSTOMER FINDINGS.

    Description of Event or Problem · 1

    A POSITIVE ADVIA CENTAUR (B)(6) RESULT WAS OBTAINED FOR A PT SAMPLE AND CONFIRMED USING THE ADVIA CENTAUR CONFIRMATORY ASSAY. THE PT SAMPLE WAS RUN ON FOUR DIFFERENT ADVIA CENTAURS WITH THE SAME RESULT EVERY TIME. THE CUSTOMER TESTED THE PT SAMPLE ON AN ALTERNATE METHOD AND THE RESULT WAS NEGATIVE FOR (B)(6) . PT 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 145

    Patients

    Seq Age Sex Outcome Treatment
    1