BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS ECI CHEMISTRY SYSTEM

    MDR report key: 1045183 · Received May 9, 2008

    Report

    Report Number
    1319681-2008-00129
    Event Type
    Malfunction
    Date Received
    May 9, 2008
    Date of Event
    April 9, 2008
    Report Date
    April 10, 2008
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INTO THIS EVENT DETERMINED THAT THE VITROS ECI WAS OPERATING AS INTENDED. THE PATIENT RESULTS WERE ASSOCIATED WITH THE INCORRECT PATIENT NAME AS A RESULT OF USER ERROR WHILE EDITING PATIENT DEMOGRAPHIC INFORMATION FOR A NEW SAMPLE ID BEFORE CLEARING THE PREVIOUS SAMPLE ID. THE CUSTOMER HAS MADE ALL OPERATORS AWARE OF THE ISSUE, SO IT CAN BE PREVENTED IN THE FUTURE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT RESULTS FROM THREE PATIENT SAMPLES PROCESSED ON THE VITROS ECI CHEMISTRY SYSTEM WERE ASSOCIATED WITH THE INCORRECT PATIENT NAMES. THE CUSTOMER IDENTIFIED THE DISCREPANCY AND THE VITROS ECI RESULTS WERE NOT REPORTED. THERE WAS NO REPORT OF PATIENT 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 CHEMISTRY SYSTEM IMMUNODIAGNOSTIC ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1