BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTICS PRODUCTS ANTI-HCV REAGENT PACK

    MDR report key: 2083582 · Received May 10, 2011

    Report

    Report Number
    3007111389-2011-00053
    Event Type
    Malfunction
    Date Received
    May 10, 2011
    Date of Event
    March 23, 2011
    Report Date
    May 10, 2011
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    MZO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT (B)(6) VITROS ANTI-HCV RESULTS WERE OBTAINED FOR TWO SAMPLES FROM A SINGLE PATIENT PROCESSED ON THE VITROS 5600 INTEGRATED SYSTEM. THE INVESTIGATION WAS UNABLE TO DETERMINE A DEFINITIVE ROOT CAUSE. HOWEVER, THE POSSIBILITY THAT THE PATIENT WAS RECENTLY INFECTED WITH (B)(6) AND IS IN AN EARLY STAGE OF (B)(6), AS WELL AS METHOD TO METHOD SENSITIVITY DIFFERENCES COULD NOT BE RULED OUT AS CONTRIBUTING FACTORS. THE ROOT CAUSE OF THIS EVENT IS UNKNOWN.

    Description of Event or Problem · 1

    A CUSTOMER OBTAINED NEGATIVE VITROS ANTI-HCV RESULTS ((B)(6)) FOR TWO SAMPLES FROM A SINGLE PATIENT PROCESSED ON THE VITROS 5600 INTEGRATED SYSTEM. THE VITROS ANTI-HCV RESULTS WERE DISCORDANT WHEN COMPARED TO RESULTS OBTAINED USING ALTERNATE METHODS ((B)(6)) AND ARE THEREFORE CONSIDERED TO BE (B)(6) RESULTS. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THE (B)(6) RESULTS WERE NOT RELEASED FROM THE LABORATORY. THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITROS IMMUNODIAGNOSTICS PRODUCTS ANTI-HCV REAGENT PACK IN-VITRO DIAGNOSTIC MZO ORTHO-CLINICAL DIAGNOSTICS 2720

    Patients

    Seq Age Sex Outcome Treatment
    1