BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 5, 1 FS CHEMISTRY SYSTEM

    MDR report key: 1070012 · Received July 2, 2008

    Report

    Report Number
    1319681-2008-00205
    Event Type
    Malfunction
    Date Received
    July 2, 2008
    Date of Event
    June 4, 2008
    Report Date
    June 5, 2008
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS, INC.
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INTO THIS EVENT DETERMINED THE PT RESULTS WERE ASSOCIATED WITH AN INCORRECT PT SAMPLE ID. THE ROOT CAUSE OF THIS EVENT IS MOST LIKELY USER ERROR ASSOCIATED WITH MANUAL SAMPLE PROGRAMMING THAT RESULTED IN THE INCORRECT PT DEMOGRAPHICS BEING ASSOCIATED WITH THE INCORRECT SAMPLE ID.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT RESULTS ON FIVE PT SAMPLES OBTAINED FROM A VITROS 5,1 FS CHEMISTRY SYSTEM WERE ASSOCIATED WITH THE INCORRECT PT NAMES AND DEMOGRAPHICS. THE VITROS 5,1 RESULTS WERE NOT REPORTED, AND THERE WERE NO REPORTS OF PT HARM AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITROS 5, 1 FS CHEMISTRY SYSTEM CHEMISTRY SYSTEM JJE ORTHO-CLINICAL DIAGNOSTICS, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1