BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXI 800 ACCESS® IMMUNOASSAY SYSTEM

    MDR report key: 2181482 · Received July 27, 2011

    Report

    Report Number
    2122870-2011-02467
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    May 5, 2011
    Report Date
    June 29, 2011
    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
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE 1/1 NEEDED TO BE ANALYZED IN AN INSERT CUP DUE TO LOW SAMPLE VOLUME. QC AND SYSTEM CHECKS WERE WITHIN SPECIFICATIONS. SERVICE WAS NOT DISPATCHED FOR THIS EVENT. A DEFINITIVE ROOT CAUSE HAS NOT BEEN DETERMINED TO DATE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC., (BEC) REGARDING A LOWER THAN EXPECTED CARCINOEMBRYONIC ANTIGEN (CEA) RESULT GENERATED BY THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM FOR ONE (1) PATIENT. THE RESULT WAS REPORTED OUT OF THE LAB AND IT WAS QUESTIONED BY THE PHYSICIAN. REPEAT TESTING AND A SUBSEQUENT SAMPLE RESULTED HIGHER AND BETTER MATCHED THE PATIENT'S CLINICAL PICTURE. 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. N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1