BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS ECI IMMUNODIAGNOSTICS SYSTEM

    MDR report key: 1020251 · Received March 26, 2008

    Report

    Report Number
    1319681-2008-00082
    Event Type
    Malfunction
    Date Received
    March 26, 2008
    Date of Event
    February 12, 2008
    Report Date
    February 29, 2008
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT THE VITROS ECI WAS OPERATING AS INTENDED. THE BIASED RESULTS WERE DUE TO USER ERROR IN THE PRE-ANALYTICAL PROCESSING OF THE PATIENT SAMPLES. THE CUSTOMER IS ROUTINELY PROCESSING SAMPLES OUTSIDE THE TUBE MANUFACTURER'S RECOMMENDATIONS. THE INSTRUCTIONS FOR USE FOR VITROS TROP I ES INDICATE THAT SAMPLES SHOULD BE THOROUGHLY SEPARATED FROM CELLULAR DEBRIS AND THAT FAILURE TO DO SO MAY LEAD TO AN ERRONEOUS RESULT.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED POSITIVELY BIASED VITROS TROP I ES RESULTS ON TWO PATIENT SAMPLES ON THE VITROS ECI IN 2008. THE BIASED RESULTS WERE REPORTED, HOWEVER, CORRECTED REPORTS WERE ISSUED PRIOR TO ANY TREATMENT. THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT. THE REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITROS ECI IMMUNODIAGNOSTICS SYSTEM IMMUNODIAGNOSTIC ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1