BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON® LX20 PRO CLINICAL SYSTEM

    MDR report key: 1659007 · Received April 14, 2010

    Report

    Report Number
    2050012-2010-00180
    Event Type
    Malfunction
    Date Received
    April 14, 2010
    Date of Event
    March 18, 2010
    Report Date
    April 14, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JGS
    PMA / PMN Number
    K965240
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRIOR TO THE EVENT, THE ISE SYSTEM WAS CALIBRATED AND QC RESULTS WERE WITHIN THE LAB'S ESTABLISHED RANGES.A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED: A) THE FSE DECONTAMINATED THE FLOW CELL.A CLEAR ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED. 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 ERRONEOUSLY LOW SODIUM (NA), CHLORIDE (CL) AND CALCIUM (CALC) RESULTS GENERATED BY THE SYNCHRON® LX20 PRO CLINICAL SYSTEM.THE SAMPLES WERE RE-TESTED ON A DIFFERENT ANALYZER AND HIGHER RESULTS WERE OBTAINED. AN EXAMPLE OF THE LOW AND THE REPEATED RESULTS IS PROVIDED.THE LOW RESULTS WERE NOT REPORTED OUT OF THE LAB. PATIENT TREATMENT WAS NOT AFFECTED IN CONNECTION WITH THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1