BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON LX 20 PRO CLINICAL SYSTEMS

    MDR report key: 2110843 · Received June 2, 2011

    Report

    Report Number
    2050012-2011-02092
    Event Type
    Malfunction
    Date Received
    June 2, 2011
    Date of Event
    May 1, 2011
    Report Date
    May 2, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K011213
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLES WERE SERUM.QC PRIOR TO AND AFTER THE EVENT WAS WITHIN LAB-ESTABLISHED RANGES.A BCI FIELD SERVICE ENGINEER CLEANED BUILDUP FROM THE CL PORT, CLEANED THE FLOW CELL AND CHANGED REAGENTS. PERFORMANCE VERIFIED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO ERRONEOUS HIGH SODIUM (NA) AND CHLORIDE (CL) RESULTS GENERATED ON THE SYNCHRON LX 20 PRO CLINICAL SYSTEMS AFTER THE SYSTEM HAS BEEN IDLE. THE ERRONEOUS RESULTS WERE NOT REPORTED OUT OF THE LABORATORY; HENCE PATIENT TREATMENT WAS NOT IMPACTED. THE SAMPLES WERE REPEATED AND LOWER RESULTS WERE OBTAINED. THE CUSTOMER PROVIDED RESULTS FROM 2 PATIENTS. ALTHOUGH THE CUSTOMER COMPLAINED OF NA AND CL, QA NOTED THAT THE DIFFERENCE IN K RESULTS FOR ONE OF THE PATIENTS EXCEEDED ASSAY PRECISION CLAIMS.

    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. LX-20 PRO N/A

    Patients

    Seq Age Sex Outcome Treatment
    1