BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 2223166 · Received August 12, 2011

    Report

    Report Number
    2122870-2011-02869
    Event Type
    Malfunction
    Date Received
    August 12, 2011
    Date of Event
    June 21, 2008
    Report Date
    August 24, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE SITE TO INVESTIGATE THE EVENT. THE FSE INSPECTED THE INSTRUMENT AND FOUND A BROKEN DISPENSE PROBE EJECTOR PLATE. THE FSE FIXED THE INSTRUMENT ACCORDING TO BCI PROCEDURES. ALTHOUGH THE FSE ADDRESSED A HARDWARE ISSUE, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FOR THIS EVENT. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS CONDUCTED BETWEEN (B)(4), 2008 THROUGH (B)(4), 2010 FOR ADD'L REPORTABLE EVENTS.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BECKMAN COULTER, INC. (BCI) IN REGARDS TO ELEVATED ACCU TNI (TROPONIN I) RESULTS GENERATED ON A UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM. THE INITIAL ELEVATED RESULT WAS NOT REPORTED OUTSIDE THE LABORATORY. THE CUSTOMER HAS REFLEX CONDITION SETUP ON THE INSTRUMENT AND THE RESULT WERE ELEVATED. THE CUSTOMER ALIQUOTED THE SAMPLE AND RECENTRIFUGED IT AND RERAN IT ON A DIFFERENT INSTRUMENT AND THE RESULT WAS WITHIN NORMAL REFERENCE RANGE. THERE ARE NO REPORTS OF ANY ADVERSE PT CONSEQUENCE OR ANY MEDICAL INTERVENTION TO PREVENT OR PRECLUDE ANY ADVERSE PT 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 52 YR ACCESS ACCUTNI