BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 250 CHEMISTRY SYSTEM

    MDR report key: 1003313 · Received February 27, 2008

    Report

    Report Number
    1319681-2008-00056
    Event Type
    Malfunction
    Date Received
    February 27, 2008
    Date of Event
    January 26, 2008
    Report Date
    January 30, 2008
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION BY OCD DETERMINED THAT RESULTS FROM ONE PATIENT SAMPLE WAS ASSOCIATED WITH AN INCORRECT SAMPLE IDENTIFICATION NUMBER. OCD HAS EVALUATED INSTRUMENT DATALOGGERS AND DETERMINED THAT THE OPERATOR HAD MANUALLY ENTERED INFORMATION FOR THE SAMPLE ID IN QUESTION. FURTHER EVALUATION OF THE DATALOGGERS ALONG WITH THE OPERATORS STATEMENTS INDICATE THAT THE ANALYZER PERFORMED AS EXPECTED. IT APPEARS FROM THE DATALOGGER OUTPUT THAT THE ISSUE MAY BE RELATED TO THE MANUAL PROGRAMING OF THE SAMPLE ID BUT BECAUSE OF PATIENT CONFIDENTIALITY THIS IS NOT ABLE TO BE CONFIRMED. SAMPLE TRAY POSITIONING ADJUSTMENTS AND SAMPLE BAR CODE READINGS WERE CHECKED AND DETERMINED TO BE WORKING AS EXPECTED WHEN EVALUATED AFTER THE EVENT. THE OPERATOR SUBSEQUENTLY PLACED THE SAMPLES BACK ON THE INSTRUMENT AND THEY RAN WITH RESULTS AS EXPECTED. NO INCORRECT PATIENT RESULTS WERE REPORTED AND THERE WAS NO ALLEGATION OF HARM AS A RESULT OF THIS EVENT. THE MOST LIKELY CAUSE OF THE EVENT APPEARS TO BE OPERATOR ERROR, BUT BECAUSE OF THE INABILITY TO EVALUATE SAMPLE ID INFORMATION, THIS CANNOT BE CONFIRMED, THEREFORE NO CONCLUSIVE ROOT CAUSE CAN BE DETERMINED.

    Description of Event or Problem · 1

    THE OPERATOR OF A VITROS 250 CHEMISTRY SYSTEM OBSERVED PATIENT RESULTS ASSOCIATED WITH INCORRECT SAMPLE IDENTIFICATION NUMBER. THE LABORATORY DID NOT REPORT ANY RESULTS FOR THE SAMPLE DETERMINED TO HAVE AN INCORRECT SAMPLE IDENTIFICATION NUMBER, AND THERE WAS NO ALLEGATION OF HARM. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITROS 250 CHEMISTRY SYSTEM CLINICAL CHEMISTRY ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1