BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNCHRON LX I 725 CLINICAL SYSTEM

    MDR report key: 615624 · Received June 17, 2005

    Report

    Report Number
    2050012-2005-00015
    Event Type
    Other
    Date Received
    June 17, 2005
    Date of Event
    May 19, 2005
    Report Date
    June 17, 2005
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER REGARDING FALSELY LOW POTASSIUM (K) RESULTS FROM A SINGLE PT THAT WERE GENERATED BY THE SYNCHRON LX I 725 INSTRUMENT. THE CUSTOMER INDICATED THAT AN ER PT SAMPLE WAS TESTED FOR K; THE RESULT WAS 1.7MMOL/L. THE RESULT WAS REPORTED OUT OF THE LAB. THE CUSTOMER INDICATED THAT THE PT WAS ADMINISTERED K BY A BOLUS. THE LAB TESTED THE PT ORIGINAL SAMPLE FOR K ON A DIFFERENT INSTRUMENT IN THEIR LAB. THE K RESULT FROM THE DIFFERENT INSTRUMENT WAS 4.4MMOL/L WAS REPORTED TO THE ER. ON THE NEXT DAY, CUSTOMER COLLECTED A FRESH SAMPLE FROM THE PT AND TESTED IT FOR K ON BOTH INSTRUMENTS (SYNCHRON LX I 725 AND THE DIFFERENT INSTRUMENT). THE SYNCHRON LX I 725 RESULT WAS 2.5MMOL/L, AND THE DIFFERENT INSTRUMENT RESULT WAS 4.6MMOL/L. A 3RD SAMPLE WAS COLLECTED FROM THE PT AND TESTED FOR K ON BOTH INSTRUMENTS. THE SYNCHRON LX I 725 RESULT WAS 2.6MMOL/L. THE DIFFERENT INSTRUMENT RESULT WAS 4.7MMOL/L.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON LX I 725 CLINICAL SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other