BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENGEN LABORATORY AUTOMATION SYSTEM

    MDR report key: 2856850 · Received December 4, 2012

    Report

    Report Number
    1319681-2012-00234
    Event Type
    Malfunction
    Date Received
    December 4, 2012
    Date of Event
    October 23, 2012
    Report Date
    December 4, 2012
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT AN INDIVIDUAL VITROS URIC RESULT FROM A SINGLE PATIENT SAMPLE WAS ASSOCIATED WITH THE INCORRECT SAMPLE IDENTIFICATION NUMBER WHEN VIEWING THE RESULT THROUGH THE INSTRUMENT MANAGER (IM) ON THE CUSTOMER'S ENGEN LABORATORY AUTOMATION SYSTEM. THERE WAS NO EVIDENCE THAT THE ANALYZER AND/OR THE CUSTOMER¿S LIS CONTRIBUTED TO THE EVENT. THE INVESTIGATION CONCLUDED THAT THE MIS-ASSOCIATION APPEARED TO HAVE OCCURRED AT THE IM ITSELF. THE ROOT CAUSE OF THIS EVENT IS CURRENTLY UNKNOWN. USER ERROR WHILE INTERACTING WITH THE IM SOFTWARE AND/ OR IM SOFTWARE MALFUNCTION CANNOT BE RULED OUT AS POTENTIAL CONTRIBUTING FACTORS AT THIS TIME. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    THIS CUSTOMER NOTIFIED OCD THAT THEY OBSERVED AN INDIVIDUAL VITROS URIC RESULT FROM A SINGLE PATIENT SAMPLE WAS ASSOCIATED WITH THE INCORRECT SAMPLE IDENTIFICATION NUMBER ON THEIR ENGEN LABORATORY AUTOMATION SYSTEM. THE MIS-ASSOCIATION OF RESULTS WITH THE INCORRECT PATIENT MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. HOWEVER, THE AFFECTED RESULT WAS IDENTIFIED AND CORRECTED PRIOR TO RELEASING THE REPORT FROM THE LABORATORY. THERE 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 ENGEN LABORATORY AUTOMATION SYSTEM LABORATORY AUTOMATION SYSTEM JJE ORTHO-CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1