BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON® LX20 PRO ANALYZER

    MDR report key: 2091529 · Received May 17, 2011

    Report

    Report Number
    2050012-2011-01594
    Event Type
    Malfunction
    Date Received
    May 17, 2011
    Date of Event
    April 19, 2011
    Report Date
    April 19, 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
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BCI CTS (CUSTOMER TECHNICAL SUPPORT) ASSISTED THE CUSTOMER WITH REPLACING THE WASH TOWER PROBE WIPER. CTS ALSO RECOMMENDED CUSTOMER TO REPLACE REAGENT SYRINGE PLUNGER ROD AND PERFORM CUVETTE WASH PROCEDURE. A FIELD SERVICE ENGINEER (FSE) WENT ON-SITE (B)(4) 2011 BUT COULD NOT DUPLICATE THE LEAK. FSE FOUND THAT VACUUM VALVE WAS NOT OPENING AND CLOSING PROPERLY AND REPLACED IT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING INTERMITTENT CARTRIDGE CHEMISTRY (CC) CUVETTE NOT DRY FLAGS AND LIQUID LEAKING FROM A PROBE ONTO COVER IN THE SYNCHRON LX20 PRO ANALYZER. NO INJURY WAS REPORTED AND NO ERRONEOUS RESULTS WERE GENERATED.

    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