BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXI 800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 1980920 · Received February 7, 2011

    Report

    Report Number
    2122870-2011-00339
    Event Type
    Malfunction
    Date Received
    February 7, 2011
    Date of Event
    October 5, 2010
    Report Date
    October 7, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Removal / Correction Number
    N/A
    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. THE CUSTOMER SENT THE SAMPLE TO CUSTOMER PRODUCT LINE SUPPORT FOR ADDITIONAL TESTING. CPLS WAS UNABLE TO IDENTIFY A PATIENT SOURCE INTERFERENT. A DEFINITIVE ROOT CAUSE HAS NOT BEEN DETERMINED TO DATE FOR THIS EVENT. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS WITHIN THE DATE RANGE (B)(6) 2010 FOR ADDITIONAL REPORTABLE EVENTS/OCCURRENCES. THIS REPORTABLE EVENT CAPTURES THE SAMPLES FOR ONE PATIENT THAT IS RELATED TO THE PREVIOUSLY SUBMITTED MDR 2122870-2010-00695.

    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 ONE PATIENT. SUBSEQUENT TESTING ON AN ALTERNATE METHODOLOGY PRODUCED DISCORDANT LOWER RESULTS WITHIN THE NORMAL REFERENCE INTERVAL. THE ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY. 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 JJE BECKMAN COULTER INC. DXI 800 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1