BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2180543 · Received July 27, 2011

    Report

    Report Number
    2122870-2011-02582
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    June 26, 2011
    Report Date
    June 26, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER VERIFIED THAT THE WASH BUFFER TUBING WAS NOT PINCHED AND THAT ALL THE CONNECTIONS WERE TIGHT. THE CUSTOMER COULD NOT FIND ANY CRACKS OR OTHER CAUSES OF THE LEAK. THE CUSTOMER STATED TO CUSTOMER TECHNICAL SERVICES (CTS) THAT THEY NOTICED THAT THE LEAK APPEARED AGAIN AFTER CLEANING AND TROUBLESHOOTING. ON (B)(4) 2011 A BEC FIELD SERVICE ENGINEER (FSE) DISCOVERED THAT THE LEAK ORIGINATED AT THE WASH BUFFER LINE FITTING. THE FSE ATTEMPTED TO STOP THE LEAK USING TEFLON TAPE, PARAFILM AND LOC-TITE; THESE ATTEMPTS DID NOT CORRECT THE LEAK. THE FSE ORDERED AND INSTALLED A NEW WASH BUFFER RESERVOIR; NO FURTHER LEAKING WAS IDENTIFIED. HARDWARE IS THE ROOT CAUSE FOR THIS EVENT. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) TO REPORT THE FLUIDICS TRAY LEAKED WASH BUFFER ONTO THE COUNTER BY THE ACCESS 2. THE CUSTOMER WORE APPROPRIATE PPE TO HANDLE AND CLEAN THE LEAK. NO INJURY OR EXPOSURE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS® 2 IMMUNOASSAY SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER FOR CLINICAL USE JJE BECKMAN COULTER INC. ACCESS2 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1