BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON LX I 725 CLINICAL SYSTEM

    MDR report key: 2461086 · Received February 17, 2012

    Report

    Report Number
    2050012-2012-00417
    Event Type
    Malfunction
    Date Received
    February 17, 2012
    Date of Event
    January 23, 2012
    Report Date
    January 23, 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 SHE CLEANED THE CARTRIDGE CHEMISTRY SAMPLE PROBE AFTER RECEIVING OBSTRUCTION ERRORS FROM THE SYNCHRON LXI 725 CLINICAL SYSTEM. CUSTOMER REPORTED THAT WHEN SHE ATTEMPTED TO RUN THE SYSTEM AFTER HOMING, THE ANALYZER DISPLAYED CUVETTE NOT DRY ERROR. CUSTOMER REPORTED THAT LINE 3B HAD BROKEN OFF THE CUVETTE WASH STATION RINSE PROBE OF THE SYNCHRON LXI 725 CLINICAL SYSTEM. CUSTOMER REPORTED THAT ERRONEOUS RESULTS WERE NOT GENERATED. THERE WAS NO REPORT OF ANY ADVERSE EVENT OR INJURY REQUIRING MEDICAL INTERVENTION OR PATIENT TREATMENT. BEC CUSTOMER TECHNICAL SPECIALIST ASSISTED THE CUSTOMER TO REPLACE AND ALIGN THE PROBE. CUSTOMER REPORTED THAT THE CUVETTE WASH STATION WAS NOT LEAKING AFTER THE REPAIR.

    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. LX I 725 NA

    Patients

    Seq Age Sex Outcome Treatment
    1