BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS ECI IMMUNODIAGNOSTIC ANALYZER

    MDR report key: 523456 · Received February 17, 2004

    Report

    Report Number
    1319681-2004-00023
    Event Type
    Malfunction
    Date Received
    February 17, 2004
    Date of Event
    January 16, 2004
    Report Date
    January 19, 2004
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED IMPRECISE THYROID QC RESULTS ON THEIR ECI ANALYZER. A MALFUNCTION OF THIS TYPE COULD CAUSE BIASED PT RESULTS TO OCCUR IN ASSAYS THAT MAY BE USED IN CRITICAL DIAGNOSTIC APPLICATIONS. RESULTS WERE NOT REPORTED AND 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 IMMUNODIAGNOSTIC ANALYZER IMMUNODIAGNOSTIC ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA