BEUDAMED
    FDA Adverse Event Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 1880717 · Received October 25, 2010

    Report

    Report Number
    2122870-2010-00653
    Date Received
    October 25, 2010
    Date of Event
    September 29, 2010
    Report Date
    October 22, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER DID NOT REPORT ANY SYSTEM PERFORMANCE ISSUES TO BCI. SERVICE WAS OFFERED; HOWEVER THE CUSTOMER DECLINE. NO ADDITIONAL INFORMATION IS AVAILABLE. NO CLEAR ROOT CAUSE CAN BE DETERMINED FROM THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO NON-REPRODUCIBLE, FALSE POSITIVE ACCUTNI RESULTS GENERATED BY THE ACCESS 2 IMMUNOASSAY ANALYZER. THE ELEVATED RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. THE SAMPLES WERE REPEATED AND NORMAL RESULTS WERE OBTAINED. DATES OF EVENTS AND/OR DATA ARE NOT AVAILABLE. PATIENT TREATMENT WAS NOT IMPACTED BY THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS 2 IMMUNOASSAY SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1