BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON LX I 725 CLINICAL SYSTEM

    MDR report key: 2377123 · Received December 15, 2011

    Report

    Report Number
    2050012-2011-08433
    Event Type
    Malfunction
    Date Received
    December 15, 2011
    Date of Event
    November 17, 2011
    Report Date
    November 17, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K023049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS ONE TWO REPORTS RELATED TO TWO EVENTS THAT OCCURRED ON THE SAME DAY. THIS REPORT IS RELATED TO MDR#2050012-2011-08431. BEC IDENTIFIER FOR THIS COMPLAINT IS (B)(4)

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT THE TOTAL PROTEIN (TPM) MODULE REAGENT SYRINGE ON THE SYNCHRON LXI 725 CLINICAL SYSTEM WAS LEAKING FLUID. CUSTOMER REPORTED THAT MOST OF THE REAGENT HAS ALREADY DRIED UP. THE CUSTOMER REPORTED THAT THE SYRINGE WAS NOT LOOSE. CUSTOMER REPORTED THAT CALIBRATION, QUALITY CONTROL (QC) AND PATIENT RESULTS WERE NOT AFFECTED. THERE WAS NO REPORT OF ANY ADVERSE EVENT OR INJURY REQUIRING MEDICAL INTERVENTION OR PATIENT TREATMENT. BEC FIELD SERVICE ENGINEER (FSE) REPLACED THE SYRINGE.

    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