BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON® LXI® 725 CLINICAL SYSTEM

    MDR report key: 2120812 · Received June 10, 2011

    Report

    Report Number
    2050012-2011-02265
    Event Type
    Malfunction
    Date Received
    June 10, 2011
    Date of Event
    May 10, 2011
    Report Date
    May 10, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K023049
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE INFORMATION WAS NOT PROVIDED. CONTROLS WERE NOT RUN BEFORE OR AFTER THE EVENT. CUSTOMER TECHNICAL SUPPORT (CTS) INSTRUCTED THE CUSTOMER TO REPLACE THE CARTRIDGE CHEMISTRY SAMPLE PROBE AND COLLAR WASH.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO ERRONEOUS LOW CREATINE KINASE RESULT GENERATED BY THE SYNCHRON LXI 725 CLINICAL SYSTEM. THE RESULT WAS NOT REPORTED OUT OF THE LABORATORY; HENCE PATIENT TREATMENT WAS NOT IMPACTED BY THIS EVENT. THE SAMPLE WAS REPEATED AND HIGHER RESULTS WERE OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON® LXI® 725 CLINICAL SYSTEM CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. LXI 725 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1