BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 5600 INTEGRATED SYSTEM

    MDR report key: 1926054 · Received December 14, 2010

    Report

    Report Number
    1319681-2010-00274
    Event Type
    Malfunction
    Date Received
    December 14, 2010
    Date of Event
    November 4, 2010
    Report Date
    December 14, 2010
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION INTO THIS EVENT DETERMINED THAT THE VITROS 5600 INTEGRATED SYSTEM WAS OPERATING AS INTENDED.THE INVESTIGATION CONCLUDED THAT A USER ERROR OCCURRED DURING THE BATCH SAMPLE PROGRAMMING MODE CAUSING MULTIPLE SAMPLES' RESULTS TO BE ASSOICATED WITH THE SAME PATIENT DEMOGRAPHICS. THE ROOT CAUSE OF THIS EVENT IS USER ERROR WHEN MANUALLY PROGRAMMING SAMPLES.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED BY OCD OF AN EVENT INVOLVING PATIENT RESULTS BEING ASSOCIATED WITH THE INCORRECT PATIENT NAME WITH MULTIPLE SAMPLES PROCESSED ON A VITROS 5600 INTEGRATED SYSTEM. NONE OF THE AFFECTED RESULTS WERE REPORTED TO A CLINICIAN. THESE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. (B)(4)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITROS 5600 INTEGRATED SYSTEM CLINICAL CHEMISTRY ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1