BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM

    MDR report key: 2142211 · Received May 26, 2011

    Report

    Report Number
    2050012-2011-01643
    Event Type
    Malfunction
    Date Received
    May 26, 2011
    Date of Event
    August 24, 2009
    Report Date
    August 24, 2009
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K060256
    Removal / Correction Number
    Z-0863-2010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN FSE (FIELD SERVICE ENGINEER) PERFORMED THE FLOW CELL CLEANING PROCEDURE. THE ISE (ION-SELECTIVE ELECTRODE) SYSTEM WAS DECONTAMINATED, THE FLOW CELL WAS CLEANED, THE RATIO PUMP REBUILT AND THE CARBON BRIDGE REPLACED. THE INSTRUMENT WAS THEN RECALIBRATED AND QC AND PRECISION RUNS PERFORMED TO ENSURE INSTRUMENT WAS PERFORMING CORRECTLY. REPAIRS AND RECALIBRATION OF THE SYSTEM ALLEVIATED THE PROBLEM BUT NO CLEAR ROOT CAUSE WAS DETERMINED. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS CONDUCTED BETWEEN JANUARY 1, 2008 TO OCTOBER 23, 2010 FOR ADDITIONAL REPORTABLE EVENTS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BCI) THAT AN ERRONEOUSLY LOW SODIUM (NA) RESULT WAS OBTAINED ON THEIR UNICEL DXC 600I INSTRUMENT. THE RESULT WAS REPORTED OUT OF THE LAB. THE CUSTOMER RE-RAN THE PATIENT SAMPLE ON ANOTHER DXC 600 INSTRUMENT AND OBTAINED A HIGHER NA RESULT. THE AMENDED RESULT WAS REPORTED OUT OF THE LAB. WHILE THERE IS NO REPORT OF ANY ADVERSE EVENT OR SERIOUS INJURY RELATED TO THIS EVENT, IT IS UNKNOWN WHETHER THERE WAS AN MODIFICATION TO PATIENT TREATMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK