BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADVIA CENTAUR HCV ASSAY

    MDR report key: 1810799 · Received August 12, 2010

    Report

    Report Number
    1219913-2010-00092
    Event Type
    Other
    Date Received
    August 12, 2010
    Date of Event
    July 10, 2010
    Report Date
    July 28, 2010
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    MZO
    PMA / PMN Number
    P030056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS REPRESENTATIVE EXAMINED THE (B)(6) QC AND CALIBRATIONS. NO ISSUES WERE FOUND. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. THE CAUSE FOR THE NON REACTIVE ADVIA CENTAUR (B)(6) RESULTS COMPARED TO THE (B)(6) RESULTS FOR THE OTHER METHODS IS UNKNOWN. THE INSTRUCTIONS FOR USE (IFU) LIMITATION SECTION STATES: "THE RESULTS FROM THIS OR ANY OTHER DIAGNOSTIC KIT SHOULD BE USED AND INTERPRETED ONLY IN THE CONTEXT OF THE OVERALL CLINICAL PICTURE. A NEGATIVE TEST RESULT DOES NOT EXCLUDE THE POSSIBILITY OF EXPOSURE TO (B)(6)." "ASSAY PERFORMANCE CHARACTERISTICS HAVE NOT BEEN ESTABLISHED WHEN THE ADVIA CENTAUR (B)(6) ASSAY IS USED IN CONJUNCTION WITH OTHER MANUFACTURERS' ASSAYS FOR SPECIFIC (B)(6) SEROLOGIC MARKERS."

    Description of Event or Problem · 1

    A NEGATIVE ADVIA CENTAUR (B)(6) RESULT WAS OBTAINED ON A PATIENT SAMPLE. THE PATIENT SAMPLE TESTED (B)(6) WITH ANOTHER SEROLOGICAL SYSTEM AND PCR. PATIENT TREATMENT WAS NOT ALTERED OR PRESCRIBED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE NON REACTIVE ADVIA CENTAUR (B)(6) RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA CENTAUR HCV ASSAY HEPATITIS C VIRUS (ANTI-HCV) ASSAY MZO SIEMENS HEALTHCARE DIAGNOSTICS INC. NA 218

    Patients

    Seq Age Sex Outcome Treatment
    1