BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS ECI Q IMMUNODIAGNOSTIC SYSTEM

    MDR report key: 1150887 · Received September 2, 2008

    Report

    Report Number
    1319681-2008-00262
    Event Type
    Malfunction
    Date Received
    September 2, 2008
    Date of Event
    August 4, 2008
    Report Date
    August 4, 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 FOUND THAT THE CUSTOMER OBSERVED HIGHER THAN EXPECTED TSH RESULTS FOR A SINGLE PT SAMPLE AND QUALITY CONTROL SAMPLES. THE CUSTOMER RE-CALIBRATED THE TSH ASSAY AND POST CALIBRATION OBTAINED EXPECTED RESULTS. THE INVESTIGATION INCLUDED ANALYSIS OF DATALOG FILES COVERING THE TIME INTERVAL OF THE EVENT, HOWEVER, THERE IS NO INDICATION THAT THE INSTRUMENT MALFUNCTIONED. THERE IS NO INDICATION THAT THE TSH REAGENT HAS MALFUNCTIONED AS THE RE-CALIBRATION WAS PERFORMED ON THE SAME IN USE PACKAGE OF REAGENT. THE ROOT CAUSE OF THE EVENT IS UNK.

    Description of Event or Problem · 1

    A CUSTOMER OBSERVED FALSELY ELEVATED TSH RESULTS ON THE VITROS ECI Q ANALYZER. THE VITROS TSH 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.

    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