BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON LX20 PRO

    MDR report key: 1005938 · Received February 22, 2008

    Report

    Report Number
    2050012-2008-00010
    Event Type
    Malfunction
    Date Received
    February 22, 2008
    Date of Event
    February 11, 2008
    Report Date
    February 22, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K011213
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SPECIMENS WERE RUN IN 13X100 SAMPLE TUBES, 1ML AND 2ML CUPS. A FIELD SERVICE ENGINEER (FSE) WAS VISITING THE LAB AT THE TIME OF THIS EVENT AND WAS ASKED BY THE CUSTOMER TO CHECK THE INSTRUMENT. (THERE IS NO INFO WHY THE FSE WAS IN THE CUSTOMER'S LAB). THE FSE INSPECTED THE INSTRUMENT AND NOTICED THAT THE CARTRIDGE CHEMISTRIES (CC) REACTION WHEEL COVER WAS FLOODED OUT WITH A WASH SOLUTION. THE FSE STOPPED THE INSTRUMENT AND FOUND A CLOT IN THE CC SAMPLE SYRINGE WASH COLLAR VACUUM VALVE. THE FSE CLEARED THE CLOT. THE FSE CLEANED THE VALVE, CUVETTES, AND THE INSTRUMENT. THE FSE CHECKED THE PHOTOMETER, AND VERIFIED THE ANALYZER WAS OPERATING APPROPRIATELY. THE INSTRUMENT PASSED ALL VERIFICATION TESTING AND AFTER QC WAS SUCCESSFUL IT WAS RELEASED BACK TO THE CUSTOMER. THE FSE INFORMED THE LAB MGMT OF THE EVENT. ON RECUR, ANY CARTRIDGE CHEMISTRY COULD BE AFFECTED. TREATMENT INITIATED OR WITHHELD BASED ON ERRONEOUS RESULTS COULD CONTRIBUTE TO SERIOUS INJURY. A CLOT IN THE WASH STATION VALVE MAY HAVE CONTRIBUTED TO THIS EVENT. A MALFUNCTION WILL BE ASSUMED FOR THE PURPOSE OF THIS REPORT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING ERRONEOUS RESULTS FOR CARTRIDGE CHEMISTRIES (CC) THAT WERE GENERATED BY THE SYNCHRON LX20 PRO INSTRUMENT FOR MULTIPLE PT SAMPLES. IN 2008, ERRONEOUS RESULTS FOR CC FOR TWELVE (12) PTS WERE REPORTED. AFTER THE INSTRUMENT WAS SERVICED AND VERIFIED BY THE FSE, THE CUSTOMER RERUN ALL PT SAMPLES TESTED IN THE PAST 30 MINS. REPEAT RESULTS REVEALED THAT 12 SAMPLES WERE RELEASED WITH AT LEAST ONE BAD RESULT. IT IS UNK IF THERE WERE CHANGES IN TREATMENT OR MEDICATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA