BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 2223164 · Received August 12, 2011

    Report

    Report Number
    2122870-2011-02867
    Event Type
    Malfunction
    Date Received
    August 12, 2011
    Date of Event
    August 12, 2008
    Report Date
    August 18, 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

    SERVICE WAS NOT DISPATCHED TO INVESTIGATE THE EVENT. THE FIELD SERVICE ENGINEER (FSE) DID NOT EVALUATE THE INSTRUMENT. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FOR THIS EVENT. MDR # 2122870-2008-283 DOCUMENTS THE RESULTS FOR PT 1. THIS IS 2 OF 3 SEPARATE MDR REPORTS RELATED TO THREE PT EVENTS ASSOCIATED WITH A SINGLE MALFUNCTION REPORT ON DIFFERENT DAYS. REFERENCE MDR NUMBERS 2122870-2008-283 AND 02868 FOR ALL RELATED EVENTS. 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 ERRONEOUSLY ELEVATED ACCU TNI (TROPONIN I) RESULTS GENERATED ON A UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM FOR THREE PTS. THE INITIAL ERRONEOUSLY ELEVATED RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THE CUSTOMER HAS REFLEX CONDITIONS SETUP ON THE INSTRUMENT AND THE RESULTS OF THE REFLEX TESTING WERE WITHIN NORMAL REFERENCE RANGE. CORRECTED RESULTS WERE REPORTED OUTSIDE THE LABORATORY. 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 84 YR ACCESS ACCUTNI