BEUDAMED
    FDA Adverse Event Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 1771112 · Received July 27, 2010

    Report

    Report Number
    2122870-2010-00355
    Date Received
    July 27, 2010
    Date of Event
    June 24, 2010
    Report Date
    July 23, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PER CUSTOMER THE UNIT HAD RECENTLY BEEN REMOVED TO A NEW LOCATION. LEVEL 1 QC RUN PRE AND POST THE EVENT RESULTED IN IND FLAGS. LEVEL 3 QC RUN PRE AND POST THE EVENT RESULTS WERE 0PG/ML. THE INITIAL ULTRASONIC WET/DRY TEST FAILED THE DRY PORTION. A BCI FIELD SERVICE ENGINEER (FSE) NOTED DUST BUILD UP INSIDE THE INSTRUMENT. ISE CLEANED THE INSIDE OF THE UNIT AND RESET THE UNIT CONNECTION. FSE PERFORMED WET/DRY TEST AND PRECISION RUN TEST AND BOTH MET THE SPECIFICATION. A CLEAR ROOT CAUSE CAN NOT BE DETERMINED FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER (BC) IN REGARDS TO INCONSISTENT BNP RESULTS ON TWO PATIENTS GENERATED BY ACCESS 2 IMMUNOANALYZER. THE RESULTS WERE REPORTED OUT OF THE LABORATORY. IT IS UNKNOWN IF CUSTOMER TREATMENT HAS BEEN AFFECTED 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