BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON LX20 PRO CLINICAL SYSTEM

    MDR report key: 1338575 · Received December 19, 2008

    Report

    Report Number
    2050012-2008-00088
    Event Type
    Malfunction
    Date Received
    December 19, 2008
    Date of Event
    November 25, 2008
    Report Date
    December 19, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K965240
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    THE SPECIMEN WAS DRAWN IN A 13X100 SST TUBE AND HAD BEEN STORED IN THE REFRIGERATOR FOR 7 HOURS. PRIOR TO THE EVENT, THE ION SELECTIVE ELECTRODE (ISE) SYSTEM HAD BEEN CALIBRATED AND THE ISE QC RESULTS WERE WITHIN THE LAB'S ESTABLISHED RANGES. IN 2008, THE CUSTOMER NOTICED BUBBLES IN THE FLOW CELL. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED: THE FSE CLEANED THE FLOW CELL AND REGENT LINE, AND REPLACED NA, K, AND CL ELECTRODES. A CULTURE TAKEN THE SAME DAY, WAS POSITIVE FOR BACTERIAL GROWTH AND THE ISE SYSTEM WAS DECONTAMINATED. THE FOLLOWING MONTH, THE CUSTOMER REPORTED ISE CALIBRATION FAILURES AND THE RATIO PUMP WAS REPLACED THE NEXT DAY. AS OF SIX DAYS LATER, THERE HAVE BEEN NO FURTHER PROBLEMS WITH THE ISE PERFORMANCE. ALTHOUGH THE FSE DECONTAMINATED THE ISE SYSTEM AND REPLACED SEVERAL HARDWARE COMPONENTS, A CLEAR ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED TO DATE. 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 AN ERRONEOUSLY ELEVATED POTASSIUM (K) RESULT GENERATED BY THE SYNCHRON LX20 PRO CLINICAL SYSTEM FOR A SINGLE PT. CUSTOMER INDICATED THAT A PT SAMPLE WAS TESTED FOR K AND A RESULT OF 5.2MMOL/L WAS REPORTED OUT OF THE LAB. THE PT WAS SENT BY THE PHYSICIAN TO AN EMERGENCY ROOM (ER) FOR EVAL. THE PT WA REDRAWN AT A DIFFERENT HOSPITAL AND K RESULT WAS NORMAL, 4.6MMOL/L. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA