BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON LX 20 PRO CLINICAL SYSTEMS

    MDR report key: 1749983 · Received July 8, 2010

    Report

    Report Number
    2050012-2010-00426
    Event Type
    Malfunction
    Date Received
    July 8, 2010
    Date of Event
    June 6, 2010
    Report Date
    July 8, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K011213
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER DOES NOT RUN PATIENT SAMPLES AT THE FACILITY. SERVICE WAS NOT DISPATCHED. IF AN UDR REAGENT CARTRIDGE IS LEFT ONBOARD THE INSTRUMENT DURING WAVELENGTH CHANGE, THE UNIT MAINTAINS THE PREVIOUS WAVELENGTH.

    Description of Event or Problem · 1

    A CUSTOMER, THAT DEVELOPS USER-DEFINED REAGENTS (UDR), CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS LX20 PRO SYNCHRON CLINICAL SYSTEMS NOT APPLYING THE NEW WAVELENGTH DURING ASSAY DEVELOPING WHEN THE CUSTOMER CHANGED THE WAVELENGTH OF THE ASSAY AND RECALIBRATED. THE CUSTOMER NOTICED NO DIFFERENCE IN WAVELENGTH TO THE RUN BETWEEN OLD AND NEW CALIBRATION. THIS WAS NOT REPORTED OUT OF THE LABORATORY. THE LABORATORY DOES NOT RUN PATIENT SAMPLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON LX 20 PRO CLINICAL SYSTEMS CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1