BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS ECI Q IMMUNODIAGNOSTIC SYSTEM

    MDR report key: 1083757 · Received July 24, 2008

    Report

    Report Number
    1319681-2008-00221
    Event Type
    Malfunction
    Date Received
    July 24, 2008
    Date of Event
    June 26, 2008
    Report Date
    June 26, 2008
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INTO THIS EVENT SHOWED THAT THE EVENT WAS RELATED TO THE INSTRUMENT PERFORMANCE. THE FIELD ENGINEER ADDRESSED THE WELL- WASH SUBSYSTEM AND POST SERVICE THE INSTRUMENT WAS RETURNED TO EXPECTED OPERATION. THE ROOT CAUSE OF THE EVENT IS INSTRUMENT RELATED.

    Description of Event or Problem · 1

    A CUSTOMER OBSERVED A SINGLE FALSELY ELEVATED TROP I ES RESULT ON THE VITROS ECI ANALYZER. BIASED RESULTS WERE NOT RELEASED IN ACCORDANCE WITH THE LABORATORY'S INTERNAL POLICY OF REPEATING ELEVATED TROP PATIENT SAMPLES PRIOR TO RELEASE. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF RELEASED. THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTH CLINICAL DIAGNOSTICS INC.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1