BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON® LX20 PRO ANALYZER

    MDR report key: 1984342 · Received February 10, 2011

    Report

    Report Number
    2050012-2011-00419
    Event Type
    Malfunction
    Date Received
    February 10, 2011
    Date of Event
    January 13, 2011
    Report Date
    January 13, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K011213
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND PERFORMED TROUBLESHOOTING (TS) ON THE SYSTEM AND FOUND THAT THERE WAS A PIN HOLE LEAK IN THE TUBING UNDER THE ROCKER VALVE ASSEMBLY. THE FSE REPLACED THE VALVE TUBING, CALIBRATED CHEMISTRIES AS NEEDED, AND RAN CUSTOMER QC.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) STATING THAT THE SYNCHRON LX20 PRO CHEMISTRY ANALYZER WAS LEAKING FROM THE HYDROPNEUMATIC (HYDRO) AREA, BUT COULD NOT LOCATE THE SOURCE. NO INJURY OR OPERATOR EXPOSURE WAS REPORTED FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON® LX20 PRO ANALYZER CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. LX 20 PRO N/A

    Patients

    Seq Age Sex Outcome Treatment
    1