BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 800 SYNCHRON SYSTEM

    MDR report key: 2142187 · Received May 26, 2011

    Report

    Report Number
    2050012-2011-01650
    Event Type
    Malfunction
    Date Received
    May 26, 2011
    Date of Event
    December 6, 2009
    Report Date
    December 7, 2009
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    Z-0863-2010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2009, AN FSE (FIELD SVC ENGINEER) PERFORMED THE FLOW CELL CLEANING PROCEDURE. THE ISE (ION-SELECTIVE ELECTRODE) SYSTEM WAS DECONTAMINATED AND ALL OF THE ASSOCIATED TUBING WAS REPLACED. THIS ALLEVIATED THE PROBLEM BUT NO CLEAR ROOT CAUSE WAS DETERMINED. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS CONDUCTED BETWEEN (B)(4) 2008 TO (B)(4) 2010 FOR ADDITIONAL REPORTABLE EVENTS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO BECKMAN COULTER, INC (BCI) ON (B)(6) 2009 THAT ERRONEOUSLY LOW SODIUM (NA) RESULTS WERE OBTAINED ON THEIR UNICEL DXC 800 INSTRUMENT. CUSTOMER REPORTED THAT THEY HAVE BEEN EXPERIENCING LOW NA DRIFT ISSUES ALONG WITH LOW ANION GAPS. NO ERRONEOUS NA RESULTS WERE REPORTED OUT OF THE LAB. THE CUSTOMER REPLACED THE NA ELECTRODE AND LATER REPORTED THAT PSEUDOMONAS WAS GROWING IN THE ISE (ION-SELECTIVE ELECTRODE) REFERENCE LINE. THERE WERE NO REPORTS OF SERIOUS INJURY OR ADVERSE EVENTS ASSOCIATED WITH THIS EVENT AND THERE WERE NO REPORTS OF ANY MODIFICATION TO PT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL DXC 800 SYNCHRON SYSTEM JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK