BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM

    MDR report key: 2252682 · Received September 9, 2011

    Report

    Report Number
    2050012-2011-05270
    Event Type
    Malfunction
    Date Received
    September 9, 2011
    Date of Event
    March 14, 2009
    Report Date
    March 20, 2009
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JGS
    PMA / PMN Number
    K060256
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS NOT REQUESTED. THE CAUSE OF THE EVENT WAS DETERMINED TO BE USER ERROR. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS CONDUCTED BETWEEN (B)(4) 2008 AND (B)(4) 2010 FOR ADDITIONAL REPORTABLE EVENTS.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BECKMAN COULTER, INC. (BCI) TO REPORT THAT THEIR UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM GAVE ERRONEOUSLY LOW SODIUM (NA) RESULTS FOR FIVE PATIENT SAMPLES. THE ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY. THERE WERE NO CHANGES TO PATIENT TREATMENT AS A RESULT OF THIS EVENT. THERE WERE NO REPORTS OF DEATH OR SERIOUS INJURY. THE CUSTOMER STATED THAT THE ERRONEOUS RESULTS WERE ALL WITHIN THE RANGE OF 110 TO 112 MMOL/L. SAMPLES WERE REDRAWN FROM THE PATIENTS AND RUN ON A DIFFERENT ANALYZER. THE REPEATED NA RESULTS WERE ALL WITHIN THE REFERENCE RANGE. AMENDED REPORTS WERE ISSUED. THE CUSTOMER DISCOVERED THAT THE OPERATOR HAD LOADED A 2 LITER BOTTLE OF WASH CONCENTRATE II INTO THE POSITION ON THE SYSTEM DESIGNATED FOR THE ELECTROLYTE BUFFER SOLUTION. LOADING THE ELECTROLYTE BUFFER SOLUTION CORRECTLY AND CALIBRATING THE ION SELECTIVE ELECTRODE (ISE) CHEMISTRIES CORRECTED THE PROBLEM.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK