BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENGEN LABORATORY AUTOMATION SYSTEM

    MDR report key: 2221684 · Received August 24, 2011

    Report

    Report Number
    1319681-2011-00166
    Event Type
    Malfunction
    Date Received
    August 24, 2011
    Date of Event
    July 26, 2011
    Report Date
    August 24, 2011
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT SAMPLE RESULTS WERE MIS-ASSOCIATED WITH THE INCORRECT SAMPLE IDS FOR TWO PATIENT SAMPLES PROCESSED ON THE ENGEN LABORATORY AUTOMATION SYSTEM. THE ROOT CAUSE OF THE EVENT IS USER ERROR. THE INVESTIGATION DETERMINED THAT THE CUSTOMER FAILED TO REMOVE THE SAMPLE TUBES FROM THE CENTRIFUGE MODULE FOLLOWING A STOPPAGE OF THE MODULE AS RECOMMENDED BY THE ENGEN LABORATORY AUTOMATION SYSTEM INSTRUCTIONS FOR USE. THE ENGEN LABORATORY AUTOMATION SYSTEM CORRECTLY FLAGGED THE AFFECTED SAMPLES, AND THE CUSTOMER DID NOT APPROPRIATELY REVIEW THE SAMPLE RESULTS PRIOR TO REPORTING THEM. THE ENGEN LABORATORY AUTOMATION SYSTEM WAS OPERATING AS INTENDED. THE ROOT CAUSE OF THIS EVENT IS USER ERROR.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT RESULTS FOR TWO PATIENT SAMPLES PROCESSED ON THE ENGEN LABORATORY AUTOMATION SYSTEM WERE MIS-ASSOCIATED WITH THE INCORRECT SAMPLE IDS. THE MIS-ASSOCIATION OF RESULTS WITH THE INCORRECT PATIENT MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. RESULTS FOR THE VITROS ASSAYS TESTED (MULTIPLE ASSAYS INVOLVED) WERE INITIALLY REPORTED FROM THE LABORATORY. ONCE IDENTIFIED, CORRECTED REPORTS WERE ISSUED FOR THE AFFECTED PATIENT SAMPLES. THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC COMPLAINT NUMBER (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 NOT APPLICABLE.