BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADVIA CENTAUR CP HCV ASSAY

    MDR report key: 1946238 · Received December 28, 2010

    Report

    Report Number
    1219913-2010-00167
    Event Type
    Other
    Date Received
    December 28, 2010
    Date of Event
    November 24, 2010
    Report Date
    November 26, 2010
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    MZO
    PMA / PMN Number
    P030056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 NONREACTIVE ADVIA CENTAUR CP HCV RESULT COMPARED TO THE (B)(6) RESULT FOR THE OTHER METHOD IS UNK. THE INSTRUCTION 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 HCV ASSAY ISSUED IN CONJUNCTION WITH OTHER MANUFACTURERS' ASSAYS FOR SPECIFIC (B)(6) SEROLOGIC MARKERS."

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: THE CUSTOMER SENT THE PATIENT SAMPLE TO SIEMENS HEALTHCARE DIAGNOSTICS FOR FURTHER TESTING. THE RESULTS OBTAINED ON THE ADVIA CENTAUR HCV WAS POSITIVE (1.01 INDEX) AND INDETERMINATE BY RIBA WESTERN BLOT. SIEMENS DID NOT CONFIRM THE NEGATIVE INDEX RESPONSES OBTAINED BY THE CUSTOMER. THE SAMPLE WAS NOT CONFIRMED BY THE RIBA WESTERN BLOT.

    Description of Event or Problem · 1

    A NONREACTIVE ADVIA CENTAUR CP HCV RESULT WAS OBTAINED ON A PT SAMPLE. THE PT SAMPLE WAS TESTED AT ANOTHER SITE ON THE ADVIA CENTAUR AND THE RESULT WAS EQUIVOCAL. THE PT SAMPLE WAS REPEATED ON AN ALTERNATE METHOD AND THE RESULT WAS (B)(6). PT TREATMENT WAS NOT ALTERED OR PRESCRIBED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ADVIA CENTAUR CP HCV RESULT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1