BEUDAMED
    FDA Adverse Event Summary report: N

    ADVIA CENTAUR HBSAG ASSAY

    MDR report key: 2132270 · Received June 17, 2011

    Report

    Report Number
    1219913-2011-00086
    Date Received
    June 17, 2011
    Date of Event
    May 19, 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
    NJ, US
    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 (B)(6) 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 (B)(6) RESULT WAS OBTAINED ON A PATIENT SAMPLE AND THE (B)(6) RESULT WAS QUESTION BY THE PHYSICIAN. THE CUSTOMER SENT THE SAMPLE TO ANOTHER LABORATORY FOR CONFIRMATION TESTING AND THE REPEAT (B)(6) RESULT WAS (B)(6) WITH ANOTHER (B)(6) TEST METHOD. THERE WAS NO 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 HBSAG ASSAY HBS IMMUNOASSAY LOM SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 155

    Patients

    Seq Age Sex Outcome Treatment
    1