BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON® LX20 PRO ANALYZER

    MDR report key: 2042766 · Received April 7, 2011

    Report

    Report Number
    2050012-2011-00981
    Event Type
    Malfunction
    Date Received
    April 7, 2011
    Date of Event
    March 6, 2011
    Report Date
    March 6, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K011213
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER HAD A SPARE CC SAMPLE VALVE BUT WANTED TO MAKE SURE IT WAS THE CORRECT ONE. BCI CUSTOMER TECHNICAL SPECIALIST ASSISTED THE CUSTOMER WITH TROUBLESHOOTING AND CONFIRMED THAT THE CUSTOMER WAS ABLE TO REPLACE THE PART AND INSTRUMENT WAS RUNNING OKAY. NO SERVICE VISIT WAS NEEDED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) STATING FLUID WAS DRIPPING FROM THE CARTRIDGE CHEMISTRY (CC) SAMPLE VALVE. NO INJURY WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1