BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 3600 IMMUNODIAGNOSTIC SYSTEM

    MDR report key: 2071063 · Received April 27, 2011

    Report

    Report Number
    1319681-2011-00099
    Event Type
    Malfunction
    Date Received
    April 27, 2011
    Date of Event
    March 23, 2011
    Report Date
    April 27, 2011
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    LOM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT FALSE NEGATIVE VITROS ANTI-HCV RESULTS WERE OBTAINED FOR MULTIPLE PATIENT SAMPLES PROCESSED ON THE VITROS 3600 IMMUNODIAGNOSTIC SYSTEM. THE INVESTIGATION WAS UNABLE TO DETERMINE A DEFINITIVE ROOT CAUSE. HOWEVER, AN INSTRUMENT RELATED EVENT COULD NOT BE RULED OUT AS A CONTRIBUTING FACTOR. THE ROOT CAUSE OF THIS EVENT IS UNKNOWN.

    Description of Event or Problem · 1

    A CUSTOMER OBTAINED NEGATIVE VITROS ANTI-HCV RESULTS FOR MULTIPLE PATIENT SAMPLES PROCESSED ON THE VITROS 3600 IMMUNODIAGNOSTIC SYSTEM. THE VITROS ANTI-HCV RESULTS WERE DISCORDANT WHEN COMPARED TO RESULTS OBTAINED FROM AN ALTERNATE VITROS ANALYZER AND ARE THEREFORE CONSIDERED TO BE FALSE NEGATIVE RESULTS. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THE FALSE NEGATIVE 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)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITROS 3600 IMMUNODIAGNOSTIC SYSTEM IMMUNODIAGNOSTIC ANALYZER LOM ORTHO-CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1