BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS AHCV REAGENT PACK

    MDR report key: 979062 · Received January 15, 2008

    Report

    Report Number
    9680658-2008-00009
    Event Type
    Malfunction
    Date Received
    January 15, 2008
    Date of Event
    October 22, 2007
    Report Date
    October 22, 2007
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    MZO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INTO THIS EVENT SHOWED THAT SUBSEQUENT TESTING OF THE SAMPLE YIELDED REPEATED POSITIVE RESULTS ON TWO ALTERNATIVE METHODS. THE MOST LIKELY ROOT CAUSE OF THE EVENT IS ASSAY DESIGN. THE SAMPLE WAS HIGHLY REACTIVE TO THE NS5 HCV ANTIGEN IN THE RIBA AHCV ASSAY. THE VITROS AHCV ASSAY IS MANUFACTURED WITH A LIMITED AMOUNT OF NS5 ANTIGEN AVAILABLE FOR NS5 ANTIBODIES TO REACT WITH.

    Description of Event or Problem · 1

    A CUSTOMER OBSERVED A REPRODUCIBLE FALSE NEGATIVE AHCV RESULT FOR A PATIENT SAMPLE TESTED ON THE ECI ANALYZER. FALSE NEGATIVE RESULTS MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITROS IMMUNODIAGNOSTIC PRODUCTS AHCV REAGENT PACK IN VITRO DIAGNOSTIC MZO ORTHO-CLINICAL DIAGNOSTICS NA 2030

    Patients

    Seq Age Sex Outcome Treatment
    1