BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 2323341 · Received October 14, 2011

    Report

    Report Number
    2122870-2011-04500
    Event Type
    Malfunction
    Date Received
    October 14, 2011
    Date of Event
    September 18, 2009
    Report Date
    September 18, 2009
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DILUTION TESTING AND SCANTIBODY BLOCKER TESTING ON THE PLASMA SAMPLE WAS INCONCLUSIVE. THERE WAS NO ADD'L SAMPLE, EITHER SERUM OR PLASMA, AVAILABLE FOR ADD'L TESTING. BECKMAN COULTER INC (BCI) CONDUCTED A LITERATURE SEARCH AND FOUND NO ARTICLES REGARDING A DIFFERENCE IN TOTAL T3 RESULTS BETWEEN SERUM AND HEPARIN PLASMA. NONE WERE FOUND WHICH DESCRIBED A VERY LARGE DISCREPANCY AS SEEN IN THIS PT. SERVICE DID NOT EVALUATE THE ANALYZER. ROOT CAUSE WAS NOT DETERMINED. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW CONDUCTED BETWEEN JANUARY 1, 2008 AND OCTOBER 23, 2010 OF COMPLAINTS FOR ADD'L REPORTABLE EVENTS. THIS IS EVENT 1 OF 2 REPORTED BY THIS CUSTOMER. THE RELATED MDR IS 2122870-2011-04531.

    Description of Event or Problem · 1

    CUSTOMER REPORTED DISCREPANT TEST RESULTS FOR ACCESS TOTAL T3 (TRIIODOTHYRONINE) WERE OBTAINED FOR ONE PT WHEN USING THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM. BOTH SERUM AND HEPARIN PLASMA WERE TESTED FROM THE SAME PT. THE TEST RESULTS WERE DISCREPANT. TEST RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. NO REPORTS OF DEATH OR SERIOUS INJURY, AND NO AFFECT TO PT TREATMENT AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ACCESS TOTAL T3