BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNICEL® DXI 800 ACCESS® IMMUNOASSAY SYSTEM

    MDR report key: 1964350 · Received January 19, 2011

    Report

    Report Number
    2122870-2011-00034
    Event Type
    Injury
    Date Received
    January 19, 2011
    Date of Event
    December 21, 2010
    Report Date
    December 22, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    DHA
    PMA / PMN Number
    K023764
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLES 2 AND 3 WERE OBTAINED AFTER THE PATIENT WAS GIVEN METHOTREXATE. QC WAS WITHIN THE CUSTOMER'S ESTABLISHED RANGES PRIOR TO AND AFTER THE EVENT. PER CUSTOMER, THE SAMPLE WAS DILUTED AND RESULTS PROVED TO BE LINEAR. THE SPECIMEN WAS SENT TO A REFERENCE LAB, RESULTS HAVE NOT BEEN RECEIVED TO DATE. SERVICE WAS NOT DISPATCHED FOR THIS EVENT. A DEFINITIVE ROOT CAUSE HAS NOT BEEN DETERMINED TO DATE FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC., (BCI) REGARDING REPRODUCIBLE POSITIVE TOTAL BHCG (TBHCG) RESULTS GENERATED BY THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM FOR ONE PATIENT. A SCREENING TEST PERFORMED ON URINE SAMPLE BY AN ALTERNATE METHOD GAVE ALSO POSITIVE RESULT. THE TBHCG RESULT WAS REPORTED OUT OF THE LABORATORY AND WAS QUESTIONED BY THE PHYSICIAN. THE PATIENT WAS TREATED WITH METHOTREXATE DUE TO THE ELEVATED TBHCG RESULTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other