BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 2031949 · Received March 28, 2011

    Report

    Report Number
    2122870-2011-00847
    Event Type
    Malfunction
    Date Received
    March 28, 2011
    Date of Event
    March 6, 2011
    Report Date
    March 7, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    922823
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYSTEM PERFORMANCE INFORMATION WAS NOT PROVIDED. PER CUSTOMER, NO ERRORS WERE NOTED IN THE EVENT LOG ASSOCIATED WITH THIS EVENT. A BCI FIELDS SERVICE ENGINEER (FSE) DISCOVERED THE FLUIDICS WASTE LINE WAS DISCONNECTED. FSE RECONNECTED TE LINE AND VERIFIED SYSTEM PERFORMANCE. HARDWARE IS THE ROOT CAUSE FOR THIS EVENT

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) TO REPORT A LEAK FROM UNDERNEATH THE ACCESS IMMUNOASSAY ANALYZER. NO EXPOSURE TO BIO-HAZARDOUS LIQUID WASTE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1