BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 5,1 FS CHEMISTRY SYSTEM

    MDR report key: 1241256 · Received November 13, 2008

    Report

    Report Number
    1319681-2008-00340
    Event Type
    Malfunction
    Date Received
    November 13, 2008
    Date of Event
    October 18, 2008
    Report Date
    October 18, 2008
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INTO THIS EVENT DETERMINED THAT THE CUSTOMER RE-USES SAMPLE ID'S ON A MONTHLY BASIS. THE CUSTOMER WAS UNAWARE OF DOCUMENTATION ON RE-USING SAMPLE ID'S AND OCD TECHNICAL BULLETIN, PERTAINING TO THE RE-USE OF SAMPLE ID'S. OCD SENT THE CUSTOMER THE TECHNICAL BULLETIN. THE CUSTOMER WILL IMPLEMENT A POLICY OF DELETING RETAINED SAMPLE ID'S ON A WEEKLY BASIS. THE ROOT CAUSE OF THIS EVENT IS USER ERROR.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT RESULTS ON A SINGLE PATIENT SAMPLE OBTAINED FROM A VITROS 5,1 FS CHEMISTRY SYSTEM WERE ASSOCIATED WITH THE INCORRECT PATIENT NAME, AND THE ASSAYS PROCESSED WERE DIFFERENT, THAN THOSE DOWNLOADED FROM THE LABORATORY INFORMATION SYSTEM. THE VITROS 5,1 RESULTS WERE NOT REPORTED, AND THERE WERE NO REPORTS OF PATIENT HARM AS A RESULT OF THIS EVENT. THE 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 CHEMISTRY ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1