BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON® LX20 CLINICAL SYSTEM

    MDR report key: 1961963 · Received January 15, 2011

    Report

    Report Number
    2050012-2011-00166
    Event Type
    Malfunction
    Date Received
    January 15, 2011
    Date of Event
    December 17, 2010
    Report Date
    December 17, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K965240
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    QC AFTER THE EVENT WAS RUNNING HIGH. RECALIBRATION RESULTED IN LOWER QC AND PATIENT RESULTS. BCI FIELD SERVICE ENGINEER (FSE) VISITED THE SITE ON (B)(6) 2010, AND REPLACED A CRACKED RATIO PUMP, CRACKED EIC (ELECTROLYTE INJECTION CUP) AND VALVES. THE FSE PERFORMED CALIBRATIONS, PRECISION TESTS, AND QC. THE RESULTS WERE ACCEPTABLE. AND THE INSTRUMENT OPERATION WAS VERIFIED. A DEFINITIVE ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED TO DATE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO ERRONEOUSLY ELEVATED SODIUM (NA), CHLORIDE (CL), CARBON DIOXIDE (CO2), POTASSIUM (K), AND CALCIUM (CALC) RESULTS GENERATED BY SYNCHRON LX20 CLINICAL SYSTEM FOR TWO PATIENTS. THE RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. SUBSEQUENT TESTING ON THE SAME AND ON AN ALTERNATE INSTRUMENT PRODUCED LOWER RESULTS WITHOUT FLYERS. THERE WAS NO EFFECT TO THE PATIENTS OR TO THE USER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1