BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON LX® 20 PRO SYSTEM

    MDR report key: 2192148 · Received August 4, 2011

    Report

    Report Number
    2050012-2011-03891
    Event Type
    Malfunction
    Date Received
    August 4, 2011
    Date of Event
    July 6, 2011
    Report Date
    July 6, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K011213
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    A CUSTOMER TECHNICAL SUPPORT (CTS) INSTRUCTED THE CUSTOMER TO CHANGE THE WIPER AND CHECK THE DISPENSING AND ASPIRATION ON THE WASH PROBE; NO ISSUES WERE NOTED. THE CUSTOMER REMOVED THE REACTION WHEEL, PER CTS INSTRUCTION, AND NOTED IT WAS WET. THE CUSTOMER FOUND TWO BROKEN CUVETTES AND FLUID IN THE WHEEL WELL. THE FLUID LEAKED WAS DI WATER AND DILUTED WASH CONCENTRATE. A BEC FIELD SERVICE ENGINEER (FSE) FOUND TWO WASH/VACUUM PROBES ARE NOT ASPIRATING FLUID FROM CUVETTES. FSE REPLACED THE PROBES AND CLEANED THE INSTRUMENT. BEC INTERNAL NOTIFICATION NUMBER IS (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) TO REPORT 10 CUVETTES FAILING WATER BLANK ON THE SYSTEM. NO INJURY OR EXPOSURE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON LX® 20 PRO SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER FOR CLINICAL USE JJE BECKMAN COULTER INC. LX20 PRO N/A

    Patients

    Seq Age Sex Outcome Treatment
    1