BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON LX® I 725 CLINICAL SYSTEM

    MDR report key: 1961974 · Received January 15, 2011

    Report

    Report Number
    2050012-2011-00162
    Event Type
    Malfunction
    Date Received
    January 15, 2011
    Date of Event
    December 17, 2010
    Report Date
    December 17, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K023049
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QC WAS WITHIN THE ESTABLISHED RANGES. NO SYSTEM ERROR MESSAGE WAS NOTED. A BCI FIELD SERVICE ENGINEER (FSE) VISITED THE SITE ON (B)(4) 2010 AND REPLACED CARBON BRIDGE AND SODIUM ELECTRODES. THE FSE CALIBRATED AND PRIMED THE SYSTEM. THE FSE RAN 30 REPLICATE PRECISION AND VERIFIED THE INSTRUMENT PERFORMANCE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO ERRONEOUSLY LOW SODIUM (NA), POTASSIUM (K), CHLORIDE (CL), AND CARBON DIOXIDE (CO2) RESULTS GENERATED BY SYNCHRON LXI 725 CLINICAL SYSTEM. THE RESULTS WERE REPORTED OUT OF THE LABORATORY, AND WERE QUESTIONED BY THE PHYSICIAN. SUBSEQUENT TESTING ON AN ALTERNATE INSTRUMENT PRODUCED HIGHER RESULTS. THERE WAS NO EFFECT TO PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON LX® I 725 CLINICAL SYSTEM CLINICAL CHEMSTRY ANALYZER JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1