BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP HCV (AHCV) ASSAY

    MDR report key: 2800539 · Received October 22, 2012

    Report

    Report Number
    1219913-2012-00386
    Event Type
    Malfunction
    Date Received
    October 22, 2012
    Date of Event
    May 28, 2012
    Report Date
    September 26, 2012
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    MZO
    PMA / PMN Number
    P030056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD APPLICATION SPECIALIST (FAS) WAS SENT TO THE CUSTOMER SITE. THE PROBES WERE WASHED. IT WAS CONFIRMED THAT THE MONTHLY AND DAILY MAINTENANCE WERE PERFORMED ON TIME. THE CAUSE FOR THE DISCORDANT HCV RESULT IS UNKNOWN. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED. THE IFU STATES IN THE INTERPRETATION OF RESULTS SECTION: "SAMPLES WITH A CALCULATED VALUE GREATER THAN OR EQUAL TO 1.00 INDEX VALUE ARE CONSIDERED REACTIVE FOR IGG ANTIBODIES TO HCV. IT IS RECOMMENDED THAT THE SAMPLE BE REPEATED IN DUPLICATE. IF 2 OF THE 3 SAMPLE RESULTS ARE LESS THAN 0.80 INDEX VALUE, THE SAMPLE IS CONSIDERED NONREACTIVE. IF 2 OF THE 3 SAMPLE RESULTS ARE GREATER THAN OR EQUAL TO 1.00 INDEX VALUE, THE SAMPLE IS CONSIDERED REACTIVE AND SUPPLEMENTAL TESTING OF THE SAMPLE IS RECOMMENDED. IF 2 OF THE 3 SAMPLE RESULTS ARE GREATER THAN OR EQUAL TO 0.80 INDEX VALUE AND LESS THAN 1.00 INDEX VALUE, SUPPLEMENTAL TESTING OF THE SAMPLE IS RECOMMENDED. THE IFU STATES IN THE LIMITATIONS SECTION: "A NEGATIVE TEST RESULT DOES NOT EXCLUDE THE POSSIBILITY OF EXPOSURE TO OR INFECTION WITH HCV. HCV ANTIBODIES MAY BE UNDETECTABLE IN SOME STAGES OF THE INFECTION AND IN SOME CLINICAL CONDITIONS." "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 HEPATITIS C VIRUS."

    Description of Event or Problem · 1

    A (B)(6) RESULT WAS OBTAINED ON A PATIENT SAMPLE. THE PREVIOUS RESULT WAS POSITIVE. THE PATIENT WAS TESTED AGAIN FOR (B)(6). PATIENT TREATMENT WAS NOT ALTERED OR PRESCRIBED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE (B)(6) RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA CENTAUR XP HCV (AHCV) ASSAY HEPATITIS C VIRUS (ANTI-HCV) ASSAY MZO SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR