BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENGEN LABORATORY AUTOMATION SYSTEM

    MDR report key: 3180463 · Received June 20, 2013

    Report

    Report Number
    1319681-2013-00130
    Event Type
    Malfunction
    Date Received
    June 20, 2013
    Date of Event
    May 20, 2013
    Report Date
    June 20, 2013
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT RESULTS FOR A SINGLE PATIENT SAMPLE PROCESSED ON THE VITROS ENGEN LABORATORY AUTOMATION SYSTEM WERE DISCORDANT WHEN COMPARED TO THE RESULTS OBTAINED FROM THE VITROS 4600 CHEMISTRY SYSTEM. THE ROOT CAUSE OF THIS EVENT IS RELATED TO AN ISSUE WITH THE CUSTOM VITROS ENGEN LABORATORY AUTOMATION SYSTEM CONFIGURATION (.GSB) FILE. ADDITIONAL INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT RESULTS FOR A SINGLE PATIENT SAMPLE PROCESSED ON THE VITROS ENGEN LABORATORY AUTOMATION SYSTEM WERE DISCORDANT WHEN COMPARED TO THE RESULTS OBTAINED FROM THE VITROS 4600 CHEMISTRY SYSTEM. THE AFFECTED RESULTS WERE REPORTED OUT OF THE LABORATORY. THIS DISCORDANCE COULD OCCUR UNDETECTED POTENTIALLY LEADING TO INAPPROPRIATE PHYSICIAN ACTION. THE INCIDENT WAS REPORTED TO THE PATHOLOGIST FOR REVIEW HOWEVER A CORRECTED REPORT WAS NOT ISSUED. 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
    280838 ENGEN LABORATORY AUTOMATION SYSTEM LABORATORY AUTOMATION SYSTEM JJE ORTHO-CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1