BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 2060437 · Received April 17, 2011

    Report

    Report Number
    2122870-2011-01021
    Event Type
    Malfunction
    Date Received
    April 17, 2011
    Date of Event
    March 17, 2011
    Report Date
    March 17, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A BCI FIELD SERVICE ENGINEER (FSE) REPLACED THE PERISTALTIC PUMP TUBING AND FLUSHING THE LINE BETWEEN THE PUMP AND THE VACUUM JAR, WHICH CORRECTED THE VACUUM ISSUE. FSE VERIFIED THE INSTRUMENT PRESSURE WAS OPERATING WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) HOTLINE TO TROUBLESHOOT A FLUID LEAK FROM UNDERNEATH THE ACCESS 2 IMMUNOASSAY ANALYZER AND VACUUM UNDER LIMIT ERROR MESSAGE. NO REPORT OF INJURY TO THE USER. THE CUSTOMER DID NOT SEEK OR NEED MEDICAL ATTENTION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1