BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON LX 20 CLINICAL SYSTEMS

    MDR report key: 1951674 · Received January 6, 2011

    Report

    Report Number
    2050012-2011-00040
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Date of Event
    December 10, 2010
    Report Date
    December 10, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JGS
    PMA / PMN Number
    K965240
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QC WAS LOW, DATA NOT PROVIDED. A BCI FIELD SERVICE ENGINEER (FSE) CLEANED THE EIC, FLOW-CELL AND DRAIN TUBE. FSE REPLACED THE ION-SELECTIVE ELECTRODE (ISE) BUFFER, REFERENCE REAGENTS, NA ELECTRODE, AND VERIFIED PERFORMANCE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO ERRONEOUS LOW SODIUM (NA) RESULTS GENERATED BY THE SYNCHRON LX20 CLINICAL SYSTEM. THE ORIGINAL SAMPLES WERE REPEATED ON AN ALTERNATE INSTRUMENT AND HIGHER RESULTS WERE OBTAINED. DATA ARE NOT AVAILABLE AND THE CUSTOMER STATED THAT THE ORIGINAL NA RESULTS RECOVERED MORE THAN 5 MMOL/L THAN THE REPEATED RUN. THE ERRONEOUS RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. PATIENT TREATMENT WAS NOT IMPACTED BY THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1