BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 2083574 · Received May 10, 2011

    Report

    Report Number
    2122870-2011-01346
    Event Type
    Malfunction
    Date Received
    May 10, 2011
    Date of Event
    April 9, 2011
    Report Date
    April 13, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    MMI
    PMA / PMN Number
    K023764
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLES WERE COLLECTED IN GREINER LIHEP PLASMA TUBES AND CENTRIFUGED FOR 10 MINUTES AT 3000 G. THE SAMPLE APPEARED CLEAR UPON VISUAL INSPECTION. THE CUSTOMER DID NOT REQUIRE INSTRUMENT SERVICE AT THE TIME OF THE EVENT. PER CUSTOMER FEEDBACK, THE CUSTOMER WAS SATISFIED WITH INSTRUMENT PERFORMANCE AT THE TIME OF CONTACT. A DEFINITIVE ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED TO DATE. THE CUSTOMER DID NOT REQUIRE SERVICE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO ERRONEOUSLY ELEVATED ACCUTNI RESULT WITHIN THE RISK STRATIFICATION RANGE FOR ONE PATIENT GENERATED BY THE UNICEL DXI 800 IMMUNOASSAY ANALYZER. THE RESULT WAS REPORTED OUT OF THE LABORATORY. THE CUSTOMER REPEATS ALL ACCUTNI RESULTS BETWEEN 0.04NG/ML AND 5.0NG/ML. THE SAMPLE WAS REPEATED AND LOWER RESULT WITHIN THE NORMAL REFERENCE RANGE WAS OBTAINED. THE CUSTOMER DID NOT RECEIVE ANY REPORT OF PATIENT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PATIENT TREATMENT ATTRIBUTED OR CONNECTED TO 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. DXI800 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1