BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON® CX4 DELTA CLINICAL SYSTEM

    MDR report key: 1953349 · Received January 8, 2011

    Report

    Report Number
    2050012-2011-00016
    Event Type
    Malfunction
    Date Received
    January 8, 2011
    Date of Event
    December 9, 2010
    Report Date
    December 9, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K881498
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS A LOW VOLUME LAB AND THE CUSTOMER STATED A BOTTLE OF WASH CONCENTRATE WILL LAST ABOUT THREE TO FOUR MONTHS. THE SIMILAR INCIDENT WAS REPORTED BY THIS CUSTOMER IN SEPTEMBER (REPORT #2050012-2010-00955). THE CUSTOMER WAS SENT A REPLACEMENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO WASH CONCENTRATE BOTTLE THAT BROKE AND LEAKED ON SYNCHRON CX4 DELTA CLINICAL SYSTEM. NO INJURY WAS REPORTED AND THERE WAS NO EFFECT TO PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON® CX4 DELTA CLINICAL SYSTEM CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1