BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR CP HCV ASSAY

    MDR report key: 3021851 · Received March 26, 2013

    Report

    Report Number
    1219913-2013-00053
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Date of Event
    February 26, 2013
    Report Date
    February 27, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    MZO
    PMA / PMN Number
    P030056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE DISCORDANT ADVIA CENTAUR CP HCV RESULTS IS UNKNOWN. A SIEMENS FIELD SERVICE ENGINEER (FSE) WENT TO THE CUSTOMER SITE FOR SYSTEM INSPECTION. THE FSE CHANGED THE REAGENT DILUTOR AND PERFORMED WEEKLY MAINTENANCE. THE FSE FOUND NO ISSUE THAT MAY HAVE CONTRIBUTED TO THE DISCORDANT RESULTS. QUALITY CONTROLS WERE WITHIN ACCEPTABLE RANGE. SIEMENS HAS REQUESTED PATIENT SAMPLES. THE INFORMATION FOR USE (IFU) STATES IN THE LIMITATIONS SECTION: "(B)(6) TEST RESULT DOES NOT EXCLUDE THE POSSIBILITY OF EXPOSURE TO OR INFECTION WITH (B)(6). (B)(6) ANTIBODIES MAY BE UNDETECTABLE IN SOME STAGES OF THE INFECTION AND IN SOME CLINICAL CONDITIONS."

    Additional Manufacturer Narrative · 1

    SIEMENS FILED THE INITIAL MDR 1219913-2013-00053 ON 03/26/2013.(B)(4) 2013: ADDITIONAL INFORMATION:SIEMENS COMPLETED ITS INVESTIGATION ON THE RETURNED SAMPLE. MULTI LOT TESTING WAS PERFORMED ON THE RETURNED SAMPLE. THE SAMPLE WAS FOUND TO BE REACTIVE ON ADVIA CENTAUR AHCV LOTS 062234 AND 062235 WITH AN INDEX VALUE OF (B)(4). ON ADVIA CENTAUR LOT 062233, THE SAMPLE RESULT WAS EQUIVOCAL WITH AN INDEX OF (B)(4). SIEMENS WAS UNABLE TO CONFIRM THE (B)(6) RESULTS OBTAINED BY THE CUSTOMER.

    Description of Event or Problem · 1

    (B)(6) ADVIA CENTAUR CP HCV RESULTS WERE OBTAINED BY THE CUSTOMER ON PATIENT SAMPLES AND CONSIDERED DISCORDANT WHEN COMPARED TO OTHER HCV TEST METHOD RESULTS. THERE WAS NO REPORT OF PATIENT TREATMENT BEING PRESCRIBED OR ALTERED AND THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ADVIA CENTAUR CP HCV RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124376 ADVIA CENTAUR CP HCV ASSAY HCV IMMUNOASSAY MZO SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 234

    Patients

    Seq Age Sex Outcome Treatment
    1