BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 2172507 · Received June 24, 2011

    Report

    Report Number
    2122870-2011-02027
    Event Type
    Malfunction
    Date Received
    June 24, 2011
    Date of Event
    May 8, 2008
    Report Date
    May 15, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE SITE ON (B)(4) 2008 TO INVESTIGATE THE EVENT. THE FSE INSPECTED THE INSTRUMENT AND FOUND THAT IT WAS DUE FOR PREVENTATIVE MAINTENANCE (PM). THE FSE PERFORMED THE PM AND VERIFIED THE INSTRUMENT PER ESTABLISHED PROCEDURES AND RESULTS MET PUBLISHED PERFORMANCE SPECIFICATIONS. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FOR THIS EVENT. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS CONDUCTED BETWEEN (B)(4) 2008 THRU (B)(4) 2010 FOR ADDITIONAL REPORTABLE EVENTS.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BECKMAN COULTER, INC (BCI) IN REGARDS TO ERRONEOUS CEA RESULT GENERATED ON A UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM. THE CUSTOMER RE-RAN THE SAMPLES AND THE RESULT WAS WITHIN NORMAL REFERENCE RANGE. THE INITIAL ERRONEOUS RESULT WAS REPORTED OUTSIDE THE LABORATORY. IT IS NOT KNOWN IF THERE WAS ANY CHANGE TO THE PT TREATMENT. THERE IS NO INDICATION OF AN ADVERSE EVENT OR INDICATION OF ANY MEDICAL INTERVENTION TO PREVENT SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ACCESS CEA