BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXI 800 ACCESS® IMMUNOASSAY SYSTEM

    MDR report key: 1404433 · Received June 22, 2009

    Report

    Report Number
    2122870-2009-00212
    Event Type
    Malfunction
    Date Received
    June 22, 2009
    Date of Event
    May 8, 2009
    Report Date
    June 22, 2009
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BECKMAN COULTER INC. (BCI) WAS NOT INFORMED ABOUT THIS EVENT UNTIL 06/04/09 DURING AN INVESTIGATION INTO A SIMILAR ISSUE ON A DIFFERENT INSTRUMENT IN THE CUSTOMER'S LAB. SERVICE WAS NOT DISPATCHED FOR THIS EVENT, AND NO ADDITIONAL INFORMATION IS AVAILABLE. A MALFUNCTION WILL BE ASSUMED FOR THE PURPOSE OF THIS REPORT.

    Description of Event or Problem · 1

    A CUSTOMER OBTAINED LOWER THAN EXPECTED TEST RESULTS FOR ALPHA-FETOPROTEIN (AFP), DILUTED-BHCG, INHIBIN A, AND UNCONJUGATED ESTRIOL (UE3) FOR ONE PATIENT'S SAMPLE. THE SAMPLE WAS RE-TESTED AND RECOVERED HIGHER THAN INITIAL RESULTS. THE SPECIMEN WAS ALSO TESTED ON A DIFFERENT INSTRUMENT AND HIGHER RESULTS WERE OBTAINED. THE RESULTS WERE NOT 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 JJE BECKMAN COULTER INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1