BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS ECI IMMUNODIAGNOSTIC ANALYZER

    MDR report key: 515436 · Received January 26, 2004

    Report

    Report Number
    1319681-2004-00014
    Event Type
    Malfunction
    Date Received
    January 26, 2004
    Date of Event
    December 28, 2003
    Report Date
    December 28, 2003
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS, INC.
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A CUSTOMER REPORTED REPEATED LOW QUALITY CONTROL RESULTS FOR TROPONIN I, CKMB AND HCG. A MALFUNCTION OF THIS TYPE COULD CAUSE BIASED RESULTS IN ASSAYS THAT MAY BE USED IN CRITICAL DIAGNOSTIC APPLICATIONS. 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, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 NA