BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON LX 20 CLINICAL CHEMISTRY SYSTEM

    MDR report key: 2521846 · Received April 6, 2012

    Report

    Report Number
    2050012-2012-00879
    Event Type
    Malfunction
    Date Received
    April 6, 2012
    Date of Event
    March 12, 2012
    Report Date
    March 12, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K011213
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT THERE WAS A LEAK UNDER THE MODULAR CHEMISTRY (MC) MODULE OF THE SYNCHRON LX 20 CLINICAL CHEMISTRY SYSTEM. CUSTOMER REPORTED THAT THE LEAKED FLUID WAS YELLOW IN COLOR AND ABOUT 15 CUBIC CENTIMETERS IN VOLUME. CUSTOMER REPORTED THAT THEY SUSPECTED THE LEAK WAS FROM THE MODULAR CHEMISTRY WASTE DRAIN. THERE WAS NO REPORT OF ERRONEOUS RESULTS GENERATED. THERE WAS NO REPORT OF ANY ADVERSE EVENT OR INJURY REQUIRING MEDICAL INTERVENTION OR PATIENT TREATMENT. BEC FIELD SERVICE ENGINEER (FSE) REPLACED THE MC MODULE, PERFORMED ALIGNMENTS, TESTED AND VERIFIED NO FURTHER LEAKS WERE PRESENT AFTER THE REPLACEMENT. ROOT CAUSE IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON LX 20 CLINICAL CHEMISTRY SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1