BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXI 800 ACCESS® IMMUNOASSAY SYSTEM

    MDR report key: 2233719 · Received September 2, 2011

    Report

    Report Number
    2122870-2011-03187
    Event Type
    Malfunction
    Date Received
    September 2, 2011
    Date of Event
    August 5, 2011
    Report Date
    August 5, 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
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BEC CUSTOMER TECHNICAL SUPPORT (CTS) RECOMMENDED CEASING INSTRUMENT PROCESSING OF SAMPLES BUT THE CUSTOMER SAID THEY WERE DEALING WITH MORNING RUNS AND A LARGE NUMBER OF SAMPLES. THE CUSTOMER REQUESTED IMMEDIATE, AFTER-HOURS SERVICE. SERVICE WAS DISPATCHED FOR THIS EVENT AND ON-SITE ON (B)(4) 2011. THE FSE FOUND THAT THE WASH BUFFER PERISTALTIC TRANSFER PUMP TUBING HAD A HOLE IN IT CAUSING THE LEAKAGE. THE FSE REPLACED THE TUBING IN BOTH THE WASH BUFFER AND WASTE TRANSFER PUMP. THE CUSTOMER RAN AND VERIFIED CONTROLS. HARDWARE IS THE ROOT CAUSE OF THE EVENT. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER, INC. (BEC) CONCERNING A LEAK FROM UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM. THE CUSTOMER STATED THE LEAK STARTED AS SMALL SPOTS BUT CONTINUED TO GET WORSE WITH CONTINUED OPERATION OF THE INSTRUMENT. THE LEAK WAS CONTAINED WITH A PAPER TOWELS PLACED ON THE FLOOR. THE CUSTOMER WAS WEARING GLOVES ON AND STATED THERE WAS NO DIRECT BARE SKIN CONTACT WITH THE FLUID. MSDS WAS NOT REVIEWED, BUT THE FACILITY HAS AN EXPOSURE CONTROL PLAN IN PLACE. THERE WAS NO REPORT OF INJURY. THE CUSTOMER WAS NOT QUESTIONING ANY PATIENT RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXI 800 ACCESS® IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER, INC. DXI 800 NA

    Patients

    Seq Age Sex Outcome Treatment
    1