BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 600 SYNCHRON CLINICAL SYSTEM

    MDR report key: 2223253 · Received August 12, 2011

    Report

    Report Number
    2050012-2011-04421
    Event Type
    Malfunction
    Date Received
    August 12, 2011
    Date of Event
    April 8, 2008
    Report Date
    April 9, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS REPORT 31 OF 35 MEDWATCH REPORTS FILED FOR THIS EVENT FOR PT 31 OF 35 PTS. SERVICE WAS NOT REQUESTED. THE CUSTOMER WAS PROVIDED WITH THE APPROVED ALTERNATE FLOW CELL MAINTENANCE CLEANING PROCEDURE. THE CUSTOMER STATED THAT THEY HAVE INCREASED THE QC RUN FREQUENCY TO EVERY FOUR HOURS. THE EVENT APPEARS TO BE RELATED TO THE WEEKLY FLOWCELL MAINTENANCE CLEANING, BUT A CLEAR ROOT CAUSE HAS NOT BEEN DETERMINED. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS CONDUCTED BETWEEN (B)(4) 2008 AND (B)(4) 2010 FOR ADD'L REPORTABLE EVENTS.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BECKMAN COULTER, INC. (BCI) TO REPORT THAT THEIR UNICEL DXC 600 SYNCHRON CLINICAL SYSTEM GAVE ERRONEOUSLY LOW SODIUM (NA) AND/OR CALCIUM (CALC) RESULTS FOR MULTIPLE PTS. THE ERRONEOUS RESULTS WERE REPORTED OUT OF THE LAB. IT IS UNK IF THERE WERE ANY CHANGES TO PT TREATMENT ASSOCIATED WITH THIS EVENT, BUT THERE HAVE BEEN NO REPORTS OF DEATH OR SERIOUS INJURY. THE CUSTOMER STATED THAT THE WEEKLY AUTOMATED FLOWCELL MAINTENANCE CLEANING PROCEDURE WAS COMPLETED AT APPROX 1:00PM. THE ION SELECTIVE ELECTRODES (ISES) WERE CALIBRATED AND A QUALITY CONTROL (QC) WAS RUN WITH GOOD RESULTS. AT APPROX 10:00PM, THE CUSTOMER WAS ALERTED TO TWO CRITICALLY LOW NA AND CALC RESULTS. ALL RESULTS RUN SINCE THE MAINTENANCE WERE REVIEWED AND IT WAS NOTED THAT NA AND CALC STARTED TO RECOVER LOW SHORTLY AFTER THE MAINTENANCE WAS COMPLETED. ALL SAMPLES RUN SINCE THE MAINTENANCE WERE REPEATED ON THE LAB'S SECOND DXC ANALYZER. THE NA AND CALC RESULTS WERE HIGHER. THE CUSTOMER STATED THAT APPROX 35 CORRECTED REPORTS WERE ISSUED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL DXC 600 SYNCHRON CLINICAL SYSTEM JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK