BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXI 800 ACCESS® IMMUNOASSAY SYSTEM

    MDR report key: 1890369 · Received November 3, 2010

    Report

    Report Number
    2122870-2010-00695
    Event Type
    Malfunction
    Date Received
    November 3, 2010
    Date of Event
    October 4, 2010
    Report Date
    November 3, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    DHX
    PMA / PMN Number
    K023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BOTH LEVELS OF CEA2 QC WERE WITHIN THE CUSTOMER'S ESTABLISHED RANGES PRIOR TO AND AFTER THE EVENT. SERVICE WAS NOT DISPATCHED FOR THIS EVENT AS THE CUSTOMER IS NOT QUESTIONING INSTRUMENT PERFORMANCE AT THIS TIME. A CLEAR ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED TO DATE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING REPRODUCIBLE, ELEVATED CARCINOEMBRYONIC ANTIGEN (CEA) RESULTS, ABOVE THE NORMAL REFERENCE INTERVAL, GENERATED BY THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM FOR TWO PATIENTS. SUBSEQUENT TESTING ON AN ALTERNATE METHODOLOGY PRODUCED DISCORDANT LOWER RESULTS WITHIN THE NORMAL REFERENCE INTERVAL FOR TWO PATIENTS. THE RESULTS WERE REPORTED OUT OF THE LAB. THE CUSTOMER DID NOT RECEIVE ANY REPORT OF PATIENT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PATIENT TREATMENT ATTRIBUTED OR CONNECTED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXI 800 ACCESS® IMMUNOASSAY SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER DHX BECKMAN COULTER INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1