BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENGEN LABORATORY AUTOMATION SYSTEM

    MDR report key: 1601493 · Received February 17, 2010

    Report

    Report Number
    1319681-2010-00025
    Event Type
    Malfunction
    Date Received
    February 17, 2010
    Date of Event
    January 20, 2010
    Report Date
    February 17, 2010
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT THE ENGEN SYSTEM WAS OPERATING AS INTENDED. THE INVESTIGATION CONCLUDED THAT THE MOST LIKELY CAUSE OF THE MIS-ASSOCIATED PATIENT INFORMATION WAS USER ERROR WHILE INTERACTING WITH THE ENGEN LAB AUTOMATION IM SPECIMEN LOOKUP SCREEN. THE OPERATOR CHANGED THE CONTENTS OF AN EXISTING SAMPLE CARRIER IN THE SPECIMEN STORAGE LOOKUP SCREEN BEFORE THE CARRIER POSITION WAS ERASED IN THE IM DATABASE WHICH IS INCONSISTENT WITH THE ENGEN LAB AUTOMATION USER DOCUMENTATION.

    Description of Event or Problem · 1

    THE CUSTOMER NOTIFIED OCD THAT THEY OBSERVED PATIENT INFORMATION (DEMOGRAPHICS) THAT WAS MIS-ASSOCIATED WITH A PATIENT SAMPLE ON THEIR ENGEN LABORATORY AUTOMATION SYSTEM. MIS-ASSOCIATION OF PATIENT DEMOGRAPHICS AND RESULTS MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. NO ERRONEOUS RESULTS WERE REPORTED OUTSIDE 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