BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON® LX20 PRO CLINICAL SYSTEM

    MDR report key: 2250215 · Received September 15, 2011

    Report

    Report Number
    2050012-2011-05280
    Event Type
    Malfunction
    Date Received
    September 15, 2011
    Date of Event
    August 18, 2011
    Report Date
    August 18, 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
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QC HAD BEEN WITHIN THE ESTABLISHED RANGES. THE INSTRUMENT WAS SHOWING REAGENT PROBE B LEVEL SENSE ERRORS AND "COMPARTMENT C NOT EMPTY" ON TRIGLYCERIDE TEST ALTHOUGH THE CARTRIDGE WAS PROPERLY PREPARED AND THE COMPARTMENT C WAS EMPTY. THE CUSTOMER FOUND LIQUID UNDER THE TRAY OVER THE REAGENT CAROUSEL AREA, AND BOTTOM OF THE COLLAR WASH FOR REAGENT PROBE B. ON (B)(4) 2011, BEC FIELD SERVICE ENGINEER (FSE) PERFORMED SERVICE ON THE INSTRUMENT. THE FSE REPLACED THE LEVEL SENSE BEAD AND PERFORMED ALL NECESSARY ALIGNMENTS. THE FSE VERIFIED REPAIR PER ESTABLISHED PROCEDURES. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT ERROR MESSAGES AND FLUID LEAKS WERE OBSERVED ON SYNCHRON LX20 PRO CLINICAL SYSTEM. BEC CUSTOMER TECHNICAL SUPPORT (CTS) ASKED THE CUSTOMER TO DISABLE THE CARTRIDGE CHEMISTRY SIDE OF THE INSTRUMENT. THE CUSTOMER INDICATED THAT NO ERRONEOUS RESULTS WERE GENERATED AND PATIENT TREATMENT WAS NOT AFFECTED. MSDS WAS NOT REVIEWED, BUT THE FACILITY HAS AN EXPOSURE CONTROL PLAN. THE OPERATOR DID NOT SEEK MEDICAL ATTENTION AND THERE WAS NO EFFECT TO PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON® LX20 PRO CLINICAL SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER, INC. LX20 PRO NA

    Patients

    Seq Age Sex Outcome Treatment
    1