BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP HCV ASSAY

    MDR report key: 2481448 · Received March 7, 2012

    Report

    Report Number
    1219913-2012-00089
    Event Type
    Malfunction
    Date Received
    March 7, 2012
    Date of Event
    February 1, 2012
    Report Date
    February 10, 2012
    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 HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE OF THE INCREASE POSITIVE RESULTS FOR LOT # 228 IS BEING INVESTIGATED. 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."

    Additional Manufacturer Narrative · 1

    (B)(4). INTERNAL STUDIES HAVE CONFIRMED THAT THIS INCREASED REACTIVE RATE IS NOT WITHIN THE RESOLVED SPECIFICITY AS STATED IN THE PERFORMANCE CHARACTERISTICS SECTION OF THE INSTRUCTIONS FOR USE, DISTRIBUTED OUTSIDE THE US: (B)(4). AS A RESULT, URGENT FIELD SAFETY NOTICE, (B)(4), WAS ISSUED TO SIEMENS' CUSTOMERS OUTSIDE THE US APRIL, 2012.

    Description of Event or Problem · 1

    FALSE POSITIVE RESULTS FROM WITHIN AN EQUIVALENT POPULATION WAS OBSERVED ON THE ADVIA CENTAUR XP HCV LOT # 228 AT THIS FACILITY. THE POSITIVE RESULTS WERE REPORTED BY THE CUSTOMER AND CONFIRMATION TESTING WAS NOT PERFORMED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ADVIA CENTAUR XP HCV RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA CENTAUR XP HCV ASSAY HEPATITIS C VIRUS (ANTI-HCV) MZO SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 228

    Patients

    Seq Age Sex Outcome Treatment
    1