BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS ECI IMMUNODIAGNOSTIC SYSTEM

    MDR report key: 1181781 · Received September 18, 2008

    Report

    Report Number
    1319681-2008-00286
    Event Type
    Malfunction
    Date Received
    September 18, 2008
    Date of Event
    August 20, 2008
    Report Date
    August 22, 2008
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INTO THIS EVENT SHOWED THAT THE EVENT WAS INSTRUMENT RELATED. FOLLOWING SERVICE TO ADDRESS INCUBATOR SHUTTLE CODES, CONSISTENT ACCEPTABLE PERFORMANCE WAS OBTAINED. POST SERVICING, 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 TWO NON-REPRODUCIBLE FALSELY ELEVATED TROP I ES RESULTS ON THE VITROS ECI ANALYZER. BIASED RESULTS WERE NOT RELEASED. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THERE WAS NO REPORT OF PT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1