BEUDAMED
    FDA Adverse Event Summary report: N

    ADVIA CENTAUR XP HBSAG ASSAY

    MDR report key: 2132268 · Received June 17, 2011

    Report

    Report Number
    1219913-2011-00084
    Date Received
    June 17, 2011
    Date of Event
    May 17, 2011
    Report Date
    May 19, 2011
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    LOM
    PMA / PMN Number
    P030049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER SITE FOR SYSTEM INSPECTION AND FOUND NO SYSTEM ISSUES THAT MAY HAVE CONTRIBUTED TO THE (B)(6) ADVIA CENTAUR XP HBSAG TEST RESULT. THE QUALITY CONTROL RESULTS WERE ACCEPTABLE. 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 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 DISCORDANT WHEN COMPARED TO REPEAT TESTING. THE CUSTOMER PERFORMED REPEAT TESTING PER LABORATORY PROTOCOL AND THE RESULT WAS NON REACTIVE. THE PATIENT WAS REDRAWN FOR FOLLOW UP HBSAG TESTING AND THE RESULT WAS NON REACTIVE. THE INITIALLY DISCORDANT (B)(6) HBSAG RESULT WAS NOT REPORTED TO THE PHYSICIAN. THERE WAS NO REPORT OF PATIENT TREATMENT BEING ALTERED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE (B)(6) ADVIA CENTAUR XP 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 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1