BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENGEN LABORATORY AUTOMATION SYSTEM

    MDR report key: 2964112 · Received February 15, 2013

    Report

    Report Number
    1319681-2013-00047
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    January 18, 2013
    Report Date
    February 15, 2013
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT TWO DIFFERENT SECONDARY TUBE LABELS WERE PLACED ON A SINGLE ALIQUOT TUBE. THE ENGEN SYSTEM CORRECTLY IDENTIFIED THE ISSUE BY GENERATING A CROSS CHECK ERROR, AS DESIGNED. A BIOMEDICAL ENGINEER CLEANED THE LABEL STAMPER, WHICH IS A DEFINED MAINTENANCE PROCEDURE FOR THE ENGEN SYSTEM. THERE ARE NO REPORTS OF ADDITIONAL OCCURRENCES OF THE EVENT FOLLOWING THIS SERVICE ACTION. A DEFINITIVE CAUSE OF THIS EVENT WAS NOT IDENTIFIED; HOWEVER, AN ISSUE WITH THE ALIQUOTER LABEL PRINTER CANNOT BE RULED OUT. THE INVESTIGATION CANNOT CONCLUDE THAT PATIENT SAMPLE RESULTS WOULD NOT BE MIS-ASSOCIATED WITH THE WRONG PATIENT IF THE EVENT WERE TO OCCUR UNDETECTED.

    Description of Event or Problem · 1

    THIS CUSTOMER DETERMINED THAT THE ENGEN LABORATORY AUTOMATION SYSTEM PLACED TWO DIFFERENT SECONDARY BARCODE LABELS ON A SINGLE SECONDARY TUBE. THE MIS-ASSOCIATION OF RESULTS WITH THE INCORRECT PATIENT HAS THE POTENTIAL TO OCCUR UNDETECTED AND MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. HOWEVER, NO RESULTS WERE AFFECTED OR REPORTED OUT OF THE LABORATORY AS THE ISSUE WAS IDENTIFIED PRIOR TO THE ALIQUOTER TUBE BEING USED. THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66414 ENGEN LABORATORY AUTOMATION SYSTEM LABORATORY AUTOMATION SYSTEM JJE ORTHO-CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1