BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON LX®I 725 SYSTEM

    MDR report key: 2165816 · Received July 17, 2011

    Report

    Report Number
    2050012-2011-03195
    Event Type
    Malfunction
    Date Received
    July 17, 2011
    Date of Event
    June 14, 2011
    Report Date
    June 14, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K023049
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BEC FIELD SERVICE ENGINEER (FSE) ASSISTED THE CUSTOMER OVER THE PHONE AND FOUND THAT THE ROOT CAUSE OF THE LEAK WAS A BROKEN FITTING AT THE BASE OF THE WASH WELL FOR THE CAP PIERCER BLADE ASSEMBLY. PER FSE'S INSTRUCTIONS, THE CUSTOMER REMOVED THE BROKEN FITTING AND REPAIRED THE INSTRUMENT'S CAP PIERCER WITH A SPARE FITTING FROM THEIR STOCK OF PARTS RECEIVED AT INSTALLATION. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) AN AUTOGLOSS LEAK FROM THE CAP PIERCER AREA OF A SYNCHRON LX I 725 SYSTEM ONTO THE FLOOR. NO FUMES WERE PRODUCED AND THE CUSTOMER WAS NOT HARMED NOR NEEDED MEDICAL TREATMENT. NO EFFECT TO PATIENT OR OPERATOR WAS REPORTED IN CONNECTION WITH THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1