BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXL 600 ACCESS® IMMUNOASSAY SYSTEM

    MDR report key: 2268350 · Received September 28, 2011

    Report

    Report Number
    2122870-2011-04007
    Event Type
    Malfunction
    Date Received
    September 28, 2011
    Date of Event
    August 31, 2011
    Report Date
    September 1, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(4) 2011. THE FSE INSPECTED THE INSTRUMENT AND DISCOVERED A HOLE IN THE WASTE PERI-PUMP TUBING. THE FSE REPLACED THE WASTE PUMP TUBING AND THE WASH BUFFER PUMP TUBING. THE FSE PRIMED THE INSTRUMENT AND NO FURTHER LEAKS WERE DETECTED. HARDWARE IS THE ROOT CAUSE OF THIS EVENT. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC., (BEC) AND REPORTED A LEAK COMING FROM THE UNICEL DXL 600 ACCESS IMMUNOASSAY SYSTEM THAT HAD FORMED A PUDDLE ON THE FLOOR. THE CUSTOMER CEASED USE OF THE INSTRUMENT AND A SERVICE VISIT WAS INITIATED BY BEC HOTLINE. THE LEAK WAS CLEANED UP AND THERE WAS NO INJURY OR EXPOSURE TO THE LEAKED FLUID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXL 600 ACCESS® IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER INC. DXI 600 NA

    Patients

    Seq Age Sex Outcome Treatment
    1