BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON LX20 PRO CLINICAL SYSTEM

    MDR report key: 1953318 · Received January 7, 2011

    Report

    Report Number
    2050012-2011-00090
    Event Type
    Malfunction
    Date Received
    January 7, 2011
    Date of Event
    December 10, 2010
    Report Date
    December 10, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K965240
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QC PRIOR TO THE EVENT WAS WITHIN LAB-ESTABLISHED RANGES. QC WAS NOT RUN AFTER THE EVENT. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND IDENTIFIED THE RATIO PUMP WAS NOT PERFORMING CORRECTLY. THE FSE REPAIRED THE RATIO PUMP AND VERIFIED PERFORMANCE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO EXHIBITING SAMPLE DRIFT ERRORS FOR A WHOLE WEEK FOR SODIUM (NA), CARBON DIOXIDE (CO2), AND CALCIUM (CALC) THAT WAS GENERATED BY THE SYNCHRON LX20 CLINICAL SYSTEM. THIS ERROR PRODUCED FALSE RESULTS FOR POTASSIUM (K), CHLORIDE (CL), AND CARBON DIOXIDE (CO2), BUT WERE NOT WERE NOT REPORTED OUT OF THE LABORATORY. THE SAMPLES WERE REPEATED ON AN ALTERNATE INSTRUMENT AND THOSE RESULTS WERE REPORTED OUT OF THE LABORATORY. PATIENT TREATMENT WAS NOT AFFECTED IN THIS EVENT.

    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 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1