BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS ECI IMMUNODIAGNOSTIC SYSTEM

    MDR report key: 938323 · Received November 5, 2007

    Report

    Report Number
    1319681-2007-00322
    Event Type
    Malfunction
    Date Received
    November 5, 2007
    Date of Event
    October 7, 2007
    Report Date
    October 8, 2007
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN OCD FIELD ENGINEER WENT TO THE SITE AND REPLACED THE INCUBATOR AND SIGNAL REAGENT MODULE TO RESOLVE THIS EVENT. THE ROOT CAUSE WAS DETERMINED TO BE INSTRUMENT RELATED, AND APPROPRIATE REPAIRS BROUGHT THE INSTRUMENT BACK TO EXPECTED OPERATION.

    Description of Event or Problem · 1

    A CUSTOMER OBSERVED IMPRECISE RESULTS FOR LOW LEVEL QC FLUIDS WITH THE VITROS TROP I ASSAY ON THEIR VITROS ECI IMMUNODIAGNOSTIC ANALYZER. NO PT SAMPLES WERE ASSAYED DURING THIS EVENT. THERE WAS NO ALLEGATION OF HARM. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 YR