BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON LX I 725

    MDR report key: 2183657 · Received July 8, 2011

    Report

    Report Number
    2050012-2011-02921
    Event Type
    Malfunction
    Date Received
    July 8, 2011
    Date of Event
    February 27, 2008
    Report Date
    February 27, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JGS
    PMA / PMN Number
    K023049
    Removal / Correction Number
    Z-0863-2010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SVC ENGINEER (FSE) VISITED THE FACILITY AND EXAMINED THE SYS. THE SYS CULTURED POSITIVE FOR PSEUDOMONAS SPP. THE FSE DECONTAMINATED THE SYS AND REPLACED SEVERAL ISE (ION-SELECTIVE ELECTRODE) MODULE PARTS. WHILE THIS MEASURE MAY HAVE RESOLVED THE PROBLEM, A CLEAR ROOT CAUSE COULD NOT BE DETERMINED; ACCORDINGLY, NO CONCLUSION CAN BE DRAWN. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS CONDUCTED BETWEEN 01/01/2008 AND 10/23/2011 FOR ADDITIONAL REPORTABLE EVENTS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT AN UNSPECIFIED NUMBER OF ERRONEOUSLY LOW SODIUM RESULTS WERE GENERATED BY THE SYNCHRON LX I 725 SYS DUE TO CONTAMINATION. CULTURES OF THE SYS WERE POSITIVE FOR PSEUDOMONAS SPP. THE INITIAL ERRONEOUS RESULTS WERE REPORTED OUT OF THE LAB. THE CUSTOMER RETESTED THE SAMPLES AND OBTAINED RESULTS WITHIN EXPECTATION. AMENDED RESULTS WERE REPORTED. THERE WAS NO CHANGE TO THE PTS' CARE OR TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON LX I 725 JGS BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ISE ELECTROLYTE REFERENCE| ISE ELECTROLYTE BUFFER