BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENGEN LABORATORY AUTOMATION SYSTEM

    MDR report key: 2001488 · Received February 25, 2011

    Report

    Report Number
    1319681-2011-00045
    Event Type
    Malfunction
    Date Received
    February 25, 2011
    Date of Event
    September 17, 2009
    Report Date
    February 25, 2011
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    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. THE INVESTIGATION DETERMINED THAT THE OPERATOR MANUALLY STOPPED THE (B)(4) LABORATORY AUTOMATION TRACK SYSTEM WHILE SAMPLES WERE BEING PROCESSED AT THE BYPASS METERING INTERFACE TO A CHEMISTRY ANALYZER. DUE TO A SOFTWARE ANOMALY IN THE (B)(4) TCAUTOMATION SOFTWARE, AN UNINTENDED SAMPLE TUBE WAS ASPIRATED, AND THE SUBSEQUENT PATIENT RESULTS WERE MIS-ASSOCIATED WITH THE INTENDED PATIENT'S SAMPLE IDENTIFICATION. THE ROOT CAUSE OF THIS EVENT IS INSTRUMENT RELATED. THE FDA'S NEW YORK DISTRICT OFFICE HAS BEEN NOTIFIED OF THIS ISSUE: INITIAL RECALL REPORT - (B)(4) LABORATORY AUTOMATION SYSTEM - 1319681-02/03/11-001-C SUBMITTED ON (B)(4) 2011.

    Description of Event or Problem · 1

    OCD IDENTIFIED THAT THIS CUSTOMER HAD OBTAINED RESULTS FROM A SINGLE PATIENT SAMPLE THAT WERE ASSOCIATED WITH THE INCORRECT SAMPLE IDENTIFICATION NUMBER WHILE USING THEIR (B)(4) LABORATORY AUTOMATION SYSTEM. THE MIS-ASSOCIATION OF RESULTS WITH THE INCORRECT PATIENT MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THE AFFECTED PATIENT RESULTS WERE REPORTED FROM THE LABORATORY. THERE WAS NO ALLEGATION 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