BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS ECI IMMUNODIAGNOSTIC SYSTEM (RECERTIFIELD)_

    MDR report key: 1070014 · Received July 2, 2008

    Report

    Report Number
    1319681-2008-00207
    Event Type
    Malfunction
    Date Received
    July 2, 2008
    Date of Event
    June 9, 2008
    Report Date
    June 9, 2008
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION HAS DETERMINED THAT FALSELY ELEVATED TROP ES RESULTS WERE OBTAINED FROM TWO DIFFERENT PATIENT SAMPLES ON ONE OF THE CUSTOMER'S TWO VITROS ECI ANALYZERS. NO FALSELY ELEVATED RESULTS WERE OBSERVED ON THE CUSTOMER'S SECOND VITROS ECI ANALYZER. THE INVESTIGATION IS ON-GOING, HOWEVER, THE CAUSE OF THE FALSELY ELEVATED RESULTS IS MOST LIKELY ANALYZER RELATED.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED TWO FALSE POSITIVE, NON-REPRODUCIBLE VITROS TROP I ES RESULTS ON TWO SEPARATE PT SAMPLES IN 2008. BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED COULD LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THE FALSELY ELEVATED RESULTS WERE 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 (RECERTIFIELD)_ IMMUNODIAGNOSTIC SYSTEM JJE ORTHO-CLINICAL DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1