BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS ECI IMMUNODIAGNOSTIC SYSTEM

    MDR report key: 739821 · Received July 20, 2005

    Report

    Report Number
    1319681-2005-00170
    Event Type
    Malfunction
    Date Received
    July 20, 2005
    Date of Event
    May 16, 2005
    Report Date
    June 20, 2005
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: INVESTIGATION INTO THIS EVENT SHOWED THAT QC RESULTS AND CALIBRATION RESULTS WERE WITHIN RANGE. DATALOGGER ANALYSIS IDENTIFIED AN INSTRUMENT CONDITION CODE FOR A REAGENT PROBE WASH VERIFICATION ERROR. A FIELD ENGINEER MADE SEVERAL VISITS TO THE SITE AND PERFORMED MULTIPLE ADJUSTMENTS, REPLACEMENTS AND REPAIRS. THE SERVICE ACTIONS RESTORED THE ANALYZER TO EXPECTED OPERATION. THE ROOT CAUSE OF THE EVENT IS INSTRUMENT MALFUNCTION.

    Description of Event or Problem · 1

    A CUSTOMER OBSERVED NEGATIVELY BIASED TSH RESULTS DURING A NYS PROFICIENCY SURVEY ON THE VITROS ECI SYSTEM. BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. NO PT RESULTS WERE REPORTED. THERE WAS NO PT OF PT HARM AS A RESULT OF THIS EVENT.

    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 NA