BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS ECI IMMUNODIAGNOSTIC SYSTEM

    MDR report key: 1202452 · Received October 8, 2008

    Report

    Report Number
    1319681-2008-00296
    Event Type
    Malfunction
    Date Received
    October 8, 2008
    Date of Event
    September 8, 2008
    Report Date
    September 9, 2008
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INTO THIS EVENT WAS UNABLE TO DETERMINE EXACT ROOT CAUSE OF THIS EVENT. SAMPLE MIXUP COULD NOT BE RULED OUT AS A POTENTIAL ROOT CAUSE OF THE EVENT. ANALYSIS OF THE INSTRUMENT DATALOGGER FILES AND QUALITY CONTROL RESULTS COULD NOT FIND ANY EVIDENCE THAT AN ANALYZER OR REAGENT ERROR HAD OCCURRED. THERE WAS NO ALLEGATION OF HARM AS A RESULT OF THIS EVENT. THE ROOT CAUSE OF THIS EVENT IS UNK.

    Description of Event or Problem · 1

    A CUSTOMER OBSERVED TWO NON REPRODUCIBLE, POSITIVELY BIASED RESULTS WITH TWO PT SAMPLES USING VITROS TSH ON A VITROS ECI ANALYZER. THERE WAS NO REPORT OF PT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS, INC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITROS ECI IMMUNODIAGNOSTIC SYSTEM IMMUNODIAGNOSTIC ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1