BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON LXI 725 CHEMISTRY ANALYZER

    MDR report key: 2345714 · Received November 4, 2011

    Report

    Report Number
    2050012-2011-07237
    Event Type
    Malfunction
    Date Received
    November 4, 2011
    Date of Event
    April 11, 2008
    Report Date
    April 11, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K023049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A BEC REP SPOKE WITH THE LEAD TECH AT THE LAB. THE LEAD TECH BELIEVES THAT THE EVENT MAY BE DUE TO OPERATOR ERROR FROM EITHER PLACING THE CUP INCORRECTLY OR USING THE WRONG TYPE OF CUP. THERE WERE NO LEVEL SENSE OR MOTION ERRORS INDICATING A HARDWARE FAILURE. THE CUSTOMER CANCELLED THE PLANNED FIELD SERVICE VISIT. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW CONDUCTED BETWEEN (B)(4) 2008 AND (B)(4) 2010 OF COMPLAINTS FOR ADD'L REPORTABLE EVENTS.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BECKMAN COULTER, INC. (BEC) TO REPORT THAT A TUBE HAD BROKEN WHEN RUN ON THEIR SYNCHRON LXI 725 CHEMISTRY ANALYZER. THERE WAS NO IMPACT TO PT SAMPLE RESULTS OR PT TREATMENT ASSOCIATED WITH THIS EVENT. THERE WAS NO EXPOSURE OR INJURY TO THE CUSTOMER. MEDICAL ATTENTION WAS NOT SOUGHT. THE CUSTOMER WAS ADVISED TO WEAR PERSONAL PROTECTIVE EQUIPMENT PRIOR TO BEGINNING TROUBLESHOOTING ACTIVITIES. IT IS UNK IF THE FACILITY HAS A RISK MANAGEMENT PLAN IN PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON LXI 725 CHEMISTRY ANALYZER JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK