BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 1062399 · Received June 17, 2008

    Report

    Report Number
    2122870-2008-00185
    Event Type
    Other
    Date Received
    June 17, 2008
    Date of Event
    April 22, 2008
    Report Date
    June 17, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SPECIMENS WERE COLLECTED INTO GREINER LITHIUM HEPARIN PST TUBES AND CENTRIFUGED AT 3,000 RPM FOR 4.5 MINUTES. PER CUSTOMER, THERE WAS NO VISIBLE FIBRIN IN ANY OF THE SAMPLES THAT PRODUCED ERRONEOUS RESULTS. SAMPLES ARE ALIQUOTED AND RE-SPUN IN AN ULTRA-CENTRIFUGE FOR 5 MINUTES BEFORE REPEAT TESTING. QC WAS WITHIN SPECIFICATIONS AND NO ERRORS WERE POSTED TO THE EVENT LOG. THE CUSTOMER DOES NOT BELIEVE THIS IS AN INSTRUMENT ISSUE AND DECLINED SERVICE. A CLEAR ROOT CAUSE FOR 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 ACCU TNI RESULTS GENERATED THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM FOR TWO PATIENTS. PATIENT A: A SAMPLE FROM THIS PATIENT WAS TESTED FOR ACCU TNI AND A RESULT OF 13.2 NG/ML WAS OBTAINED. A FRESH SAMPLE COLLECTED FROM THE PATIENT GAVE A RESULT OF 40.49 NG/ML. BOTH SAMPLES WERE RE-TESTED ON THE NEXT DAY AND 2 RESULTS OF 0.10 NG/ML WERE REPORTED OUT OF THE LAB. PATIENT B: AN INITIAL ACCU TNI RESULT WAS 0.78 NG/ML. THE ORIGINAL SAMPLE WAS RE-TESTED AND A RESULT OF 0.07 NG/ML WAS REPORTED OUT OF THE LAB. THE ERRONEOUS RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. THE CUSTOMER HAS NOT RECEIVED 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 MMI BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA