BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXI 800 ACCESS® IMMUNOASSAY SYSTEM

    MDR report key: 2348033 · Received November 23, 2011

    Report

    Report Number
    2122870-2011-05660
    Event Type
    Malfunction
    Date Received
    November 23, 2011
    Date of Event
    October 26, 2011
    Report Date
    October 26, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BECKMAN COULTER SERVICE WAS NOT DISPATCHED FOR THIS EVENT, THE ON SITE BIOMEDICAL ENGINEER WAS ABLE TO REPLACE THE CRACKED PERI-PUMP TUBING WITHOUT ISSUE. HARDWARE IS THE ROOT CAUSE OF THIS EVENT. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BECKMAN COULTER INC., (BEC) THAT A LEAK HAD OCCURRED FROM THE BACK OF THEIR UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM. THE CUSTOMER'S ON SITE BIOMEDICAL ENGINEER WAS ABLE TO DETERMINE THE LEAK HAD OCCURRED DUE TO A CRACK IN THE LIQUID WASTE PUMP TUBING. PER CUSTOMER, THERE WERE NO OCCURRENCES OF EXPOSURE OR INJURY CONNECTED TO THIS EVENT. NO PATIENT RESULTS WERE GENERATED IN CONNECTION TO THIS EVENT AND THERE IS NO REPORT OF INJURY TO THE USER.

    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 W/SPOT B N/A

    Patients

    Seq Age Sex Outcome Treatment
    1