BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS ECI IMMUNODIAGNOSTIC ANALYZER

    MDR report key: 467512 · Received June 20, 2003

    Report

    Report Number
    1319681-2003-00133
    Event Type
    Malfunction
    Date Received
    June 20, 2003
    Date of Event
    May 21, 2003
    Report Date
    May 23, 2003
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A CUSTOMER REPORTED GENERATING DISCREPANT TROPONIN I RRESULTS FOR ONE PT SAMPLE. THE INVESTIGATION DETERMINED THAT A MALFUNCTION OF THIS TYPE COULD CAUSE BIASED RESULTS IN ASSAYS THAT MAY BE USED IN CRITICAL DIAGNOSTIC APPLICATONS. 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