BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS ECI IMMUNODIAGNOSTIC ANALYZER

    MDR report key: 482104 · Received September 4, 2003

    Report

    Report Number
    1319681-2003-00179
    Event Type
    Malfunction
    Date Received
    September 4, 2003
    Date of Event
    August 8, 2003
    Report Date
    August 10, 2003
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS, INC.
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A CUSTOMER REPORTED GENERATING SEVERAL CONSECUTIVE FALSE NEGATIVE HEPATITIS B SURFACE ANTIGEN QUALITY CONTROL RESULTS. THE INVESTIGATION DETERMINED THAT 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. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA