BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON LX I 725 CLINICAL SYSTEM

    MDR report key: 2723887 · Received September 1, 2012

    Report

    Report Number
    2050012-2012-01432
    Event Type
    Malfunction
    Date Received
    September 1, 2012
    Date of Event
    August 6, 2012
    Report Date
    August 6, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K023049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 THEY HAD AN ISE (ION SELECTIVE ELECTRODES) ISSUE WITH THE SYNCHRON LXI 725 CLINICAL SYSTEM (LXI 725). CUSTOMER REPORTED THAT THE CIGAR TUBE WAS OVERFLOWING. CUSTOMER REPORTED THAT A VERY SMALL AMOUNT OF FLUID LEAKED FROM THE ELECTROLYTE FLOWCELL OUT OF THE ANALYZER. CUSTOMER REPORTED THAT THE LXI 725 SYSTEM GENERATED ERRONEOUS RESULTS. CUSTOMER REPORTED THAT THE ERRONEOUS RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. CUSTOMER REPORTED THAT PATIENT TREATMENT WAS NOT AFFECTED. THERE WAS NO REPORT OF ANY ADVERSE EVENT OR INJURY REQUIRING MEDICAL INTERVENTION OR PATIENT TREATMENT. BEC FIELD SERVICE ENGINEER (FSE) FOUND THAT THE WASTE TUBING WAS PINCHED BEHIND THE ISE MODULE. THE FSE ADJUSTED THE TUBING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON LX I 725 CLINICAL SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1