BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS ECI IMMUNODIAGNOSTIC SYSTEM

    MDR report key: 1033132 · Received April 16, 2008

    Report

    Report Number
    1319681-2008-00108
    Event Type
    Malfunction
    Date Received
    April 16, 2008
    Date of Event
    March 7, 2008
    Report Date
    March 18, 2008
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION FOUND NO EVIDENCE TO SUGGEST THAT THE VITROS ECI MALFUNCTIONED. THERE WAS NO EVIDENCE THAT THE CUSTOMER PERFORMED THE REQUIRED DAILY MAINTENANCE WHICH COULD LEAD TO BIASED TSH RESULTS. THEREFORE, THE ROOT CAUSE IS MOST LIKELY USER ERROR.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED HIGHER THAN EXPECTED VITROS TSH RESULTS FOR A SINGLE PATIENT SAMPLE ON THE VITROS ECI SYSTEM. BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED COULD LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THE RESULT WAS NOT REPORTED AND THERE WERE NO ALLEGATIONS OF HARM AS A RESULT OF THIS EVENT. THE 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