BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS ECI IMMUNODIAGNOSTIC ANALYZER

    MDR report key: 465805 · Received June 12, 2003

    Report

    Report Number
    1319681-2003-00127
    Event Type
    Malfunction
    Date Received
    June 12, 2003
    Date of Event
    May 22, 2003
    Report Date
    May 22, 2003
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS, INC.
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A CUSTOMER INFORMED AN ORTHO CLINICAL DIAGNOSTIC'S FIELD ENGINEER THAT COMPANY HAD EXPERIENCED SEVERAL FALSELY ELEVATED TOTAL BETA HCG RESULTS ON PATIENT SAMPLES. THE DEGREE OF BIAS OBSERVED MAY BE USED IN CRITICAL DIAGNOSTIC APPLICATIONS. THERE WAS NOT REPORT OF 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, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA