BEUDAMED
    FDA Adverse Event Summary report: N

    ADVIA CENTAUR XP HBSAG ASSAY

    MDR report key: 2020301 · Received March 16, 2011

    Report

    Report Number
    1219913-2011-00030
    Date Received
    March 16, 2011
    Date of Event
    February 16, 2011
    Report Date
    February 17, 2011
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    LOM
    PMA / PMN Number
    P030049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THERE ARE NO KNOWN SYSTEM ISSUES THAT MAY HAVE CONTRIBUTED TO THE (B)(6) ADVIA CENTAUR XP HBSAG TEST RESULTS ON A DILUTED PATIENT SAMPLE. THE (B)(6) HBSAG TEST RESULT WAS CONFIRMED BY THE CUSTOMER WHEN CONFIRMATORY TESTING WAS PERFORMED ON A NEAT SAMPLE. THE INSTRUCTIONS FOR USE (IFU) STATES: "IF THE SAMPLE IS GREATER THAN 50, THE SPECIMEN IS POSITIVE FOR HBSAG BY THE ADVIA CENTAUR HBSAG ASSAY. NOTE: WHEN THE ADVIA CENTAUR HBSAG ASSAY IS USED AS A STAND ALONE ASSAY (FOR EXAMPLE IN PREGNANT WOMEN BEING SCREENED TO IDENTIFY NEONATES WHO ARE AT RISK FOR ACQUIRING HBV DURING THE PERINATAL PERIOD), ALL RESULTS > 1.00 SHOULD BE CONSIDERED INITIALLY REACTIVE. REPEAT TESTING AND SUPPLEMENTAL TESTS, SUCH AS THE ADVIA CENTAUR HBSAG CONFIRMATORY ASSAY MUST BE USED TO CONFIRM THE RESULT." THE IFU DOES NOT REFERENCE CONFIRMATORY TESTING ON DILUTED (B)(6) HBSAG PATIENT SAMPLES. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A (B)(6) ADVIA CENTAUR XP HBSAG RESULT WAS OBTAINED ON A PATIENT SAMPLE AND (B)(6) WHEN THE CUSTOMER PERFORMED CONFIRMATORY TESTING ON DILUTION SAMPLES. THE PATIENT HAS A PREVIOUS HISTORY OF BEING HBSAG (B)(6). THERE WAS NO KNOWN REPORT OF PATIENT TREATMENT BEING ALTERED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE (B)(6) ADVIA CENTAUR HBSAG ASSAY 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. N/A 053

    Patients

    Seq Age Sex Outcome Treatment
    1