BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNCHRON LX I 725 CLINICAL SYSTEM

    MDR report key: 658010 · Received December 22, 2005

    Report

    Report Number
    2050012-2005-00036
    Event Type
    Other
    Date Received
    December 22, 2005
    Date of Event
    November 23, 2005
    Report Date
    December 22, 2005
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER REGARDING FALSELY ELEVATED CARBAMAZEPINE (CARB) RESULT THAT WAS GENERATED BY THE SYNCHRON LX I 725 INSTRUMENT. THE INITIAL CARB RESULT WAS ">85 UMOL/L." THE RESULT WAS REPORTED OUT OF THE LAB, BUT INDICATED THAT IS BEING CHECKED BY DILUTION. THE CUSTOMER RE-TESTED THE PT SAMPLE FOR CARB IN 1:2 DILUTION; THE RESULT WAS 21 UMOL/L. THE LAB RE-TESTED THE PT NEAT SAMPLE FOR CARB; THE RESULT WAS 21 UMOL/L. THE CUSTOMER THEN RAN ANOTHER DILUTION FOR CARB; THE RESULT WAS 21 UMOL/L. BASED ON AVAILABLE INFO, ONE DOSE OF CARB WAS STOPPED AS A RESULT OF THE FALSE HIGH RESULT OBTAINED IN THIS EVENT.

    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