BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON® LX20 PRO CLINICAL SYSTEM

    MDR report key: 2104337 · Received May 26, 2011

    Report

    Report Number
    2050012-2011-01920
    Event Type
    Malfunction
    Date Received
    May 26, 2011
    Date of Event
    April 28, 2011
    Report Date
    April 29, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K965240
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A CUSTOMER TECHNICAL SUPPORT (CTS) ASSISTED CUSTOMER IN TROUBLESHOOTING OVER THE PHONE AND THEN CALLED BACK CUSTOMER THE NEXT DAY. CUSTOMER STATED THAT CC CUVETTE NOT DRAY ERROR HAS BEEN RESOLVED, BUT STILL GETTING CC REACTION WHEEL TEMPERATURE ERRORS. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED. THE FSE INSPECTED THE INSTRUMENT, PERFORMED TROUBLESHOOTING, AND REPLACED MULTIPLE HARDWARE COMPONENTS. THE FSE PERFORMED CUVETTE AND WASH TOWER ALIGNMENTS. VALIDATION QC WAS PERFORMED WITH ACCEPTABLE RESULTS.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) AND REPORTED THAT THEY WERE GETTING CC REACTION WHEEL TEMPERATURE ERRORS AND CC CUVETTE NOT DRY ERRORS ON SYNCHRON LX20 PRO CLINICAL SYSTEM. NO INJURY WAS REPORTED IN CONNECTION WITH THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1