BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 5,1 FS CHEMISTRY SYSTEM

    MDR report key: 1222835 · Received November 6, 2008

    Report

    Report Number
    1319681-2008-00335
    Event Type
    Malfunction
    Date Received
    November 6, 2008
    Date of Event
    October 3, 2008
    Report Date
    October 8, 2008
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INTO THIS EVENT HAS DETERMINED THAT RESULTS OBTAINED FROM THE VITROS 5,1 FS ANALYZER WERE ASSOCIATED WITH AN INCORRECT PT NAME. THE ANALYZER HAD NO INSTRUMENT MALFUNCTIONS DURING THIS EVENT. THE USER WAS RE-USING SAMPLE ID'S IN A MANNER THAT IS NOT CONSISTENT WITH THE MANUFACTURERS INSTRUCTIONS FOR USE. THE MOST LIKELY ROOT CAUSE IS USER ERROR CAUSED BY A FAILURE TO ADHERE TO THE MANUFACTURERS INSTRUCTIONS FOR USE. THE USER WAS REFERRED TO THE INSTRUCTIONS FOR USE REGARDING THIS EVENT.

    Description of Event or Problem · 1

    THE OPERATOR OF A VITROS 5,1 FS CHEMISTRY SYSTEM OBSERVED RESULTS FOR A PT SAMPLE ASSOCIATED WITH THE INCORRECT PT NAME. THE LABORATORY DID NOT REPORT THE PT RESULTS FROM THIS EVENT 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 5,1 FS CHEMISTRY SYSTEM CLINICAL CHEMISTRY ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1