BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENGEN LABORATORY AUTOMATION SYSTEM

    MDR report key: 2883956 · Received December 21, 2012

    Report

    Report Number
    1319681-2012-00259
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Date of Event
    November 19, 2012
    Report Date
    December 21, 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 CONFIRMED THAT RESULTS FOR A SINGLE PATIENT SAMPLE WERE MIS-ASSOCIATED WITH AN ALTERNATE PATIENT SAMPLE IDENTIFICATION NUMBER AND DEMOGRAPHICS. THE ROOT CAUSE OF THIS EVENT IS CURRENTLY UNKNOWN. HOWEVER, THE MOST LIKELY ROOT CAUSE IS SUSPECTED AS USER ERROR WHILE INTERACTING WITH THE INSTRUMENT MANAGER SOFTWARE. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED RESULTS FROM A SINGLE PATIENT SAMPLE THAT WERE MIS-ASSOCIATED WITH THE INCORRECT SAMPLE IDENTIFICATION NUMBER AND PATIENT DEMOGRAPHICS WHILE USING THEIR ENGEN LABORATORY AUTOMATION SYSTEM. THE MIS-ASSOCIATION OF RESULTS WITH THE INCORRECT PATIENT MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THE AFFECTED PATIENT RESULTS WERE NOT REPORTED FROM THE LABORATORYAS THEY WERE IDENTIFIED PRIOR TO REPORTING. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. (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