BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 1282032 · Received December 24, 2008

    Report

    Report Number
    2122870-2008-00428
    Event Type
    Other
    Date Received
    December 24, 2008
    Date of Event
    December 13, 2008
    Report Date
    December 24, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLES WERE COLLECTED IN LITHIUM HEPARIN TUBES. QC DATA INDICATES THAT THE CUSTOMER HAD ISSUES GETTING QC TO RECOVER WITHIN THE ESTABLISHED RANGE IN 2008. BUT AFTER MULTIPLE REPEATS, IT WAS RECOVERING WITHIN THE ESTABLISHED RANGE. A DIAGNOSTIC SYSTEM CHECK WAS RUN AND FAILED THE WASHED PORTION. A FIELD SERVICE ENGINEER (FSE) WAS ONSITE TWO DAYS LATER: FSE FOUND TUBING FOR A DISPENSE PROBE CRIMPED AND CUT. FSE REPLACED THE TUBING AND CLEANED THE WASH WHEEL. FSE RE-ALIGNED DISPENSE AND ASPIRATE PROBE PLATES. FSE PERFORMED A SYSTEM CHECK WITH ALL PORTIONS PASSING. ALTHOUGH HARDWARE ISSUES ADDRESSED BY THE FSE MAY HAVE CONTRIBUTED TO THIS EVENT. A CLEAR ROOT CAUSE OF THIS EVENT HAS NOT BEEN DETERMINED TO DATE. A MALFUNCTION WILL BE ASSUMED FOR THE PURPOSE OF THIS REPORT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI), REGARDING ERRONEOUSLY ELEVATED ACCUTNI RESULTS GENERATED BY THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM FOR SEVERAL PATIENTS. CUSTOMER TESTED MULTIPLE PATIENT SAMPLES FOR ACCUTNI OBTAINED RESULTS IN THE RANGE OF 0.68 - 1.83 NG/ML. THE ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE ORIGINAL SAMPLES WERE REPEATED ON A DIFFERENT INSTRUMENT AND LOWER RESULTS IN THE RANGE OF "<0.03" - 0.13NG/ML WERE OBTAINED. PATIENTS WERE ADMITTED TO HOSPITAL DUE TO FALSELY ELEVATED ACCU TNI RESULTS. SEVERAL WERE STARTED ON MEDICATION AND UNDERWENT STRESS TESTS BEFORE BEING DISCHARGED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA