BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS ECI IMMUNODIAGNOSTIC SYSTEM

    MDR report key: 1070013 · Received July 2, 2008

    Report

    Report Number
    1319681-2008-00206
    Event Type
    Malfunction
    Date Received
    July 2, 2008
    Date of Event
    June 6, 2008
    Report Date
    June 9, 2008
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT THE VITROS ECI SIGNAL REAGENT SYSTEM WAS NOT OPERATING AS INTENDED. THIS COULD LEAD TO IMPROPER SIGNAL REAGENT DISPENSE, RESULTING IN ELEVATED TROP ES RESULTS. OCD FIELD SERVICE INVESTIGATED AND MADE NECESSARY REPAIRS, RETURNING THE VITROS ECI TO EXPECTED OPERATION. THE ROOT CAUSE OF THE FALSE POSITIVE TROP ES RESULT IS ANALYZER RELATED.

    Description of Event or Problem · 1

    THE CUSTOMER BECAME AWARE OF A FALSE POSITIVE NON-REPRODUCIBLE VITROS TROP I ES RESULT ON A PT SAMPLE WHEN REPEAT TESTING DID NOT CONFIRM THE INITIAL RESULTS. BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED COULD LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THE INITIAL RESULT WAS NOT REPORTED AND THERE WERE NO ALLEGATIONS OF 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 IMMUNODIAGNOSTIC ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1