BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 600 SYNCHRON CLINICAL SYSTEM

    MDR report key: 2252718 · Received September 9, 2011

    Report

    Report Number
    2050012-2011-05128
    Event Type
    Malfunction
    Date Received
    September 9, 2011
    Date of Event
    February 14, 2009
    Report Date
    February 15, 2009
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A BCI FIELD SERVICE ENGINEER (FSE) EVALUATED THE SYSTEM AND DETERMINED THAT THE RATIO PUMP WAS INTERMITTENTLY GIVING A PARTIAL DISPENSE. THE FSE REPLACED THE RATIO PUMP. ALTHOUGH THE EVENT OCCURRED A FEW HOURS AFTER THE FLOW CELL CLEANING PROCEDURE WAS PERFORMED, A CLEAR ROOT CAUSE HAS NOT BEEN IDENTIFIED. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS CONDUCTED BETWEEN (B)(4) 2008 AND (B)(4), 2010 FOR ADDITIONAL REPORTABLE EVENTS. THIS MDR REPRESENTS EVENT 1 OF 10 REPORTED BY THIS CUSTOMER. THIS MDR IS RELATED TO THE FOLLOWING MDRS THAT HAVE BEEN REPORTED: 2050012-2011-05129, 2050012-2011-05130, 2050012-2011-05131, 2050012-2011-05132, 2050012-2011-05133, 2050012-2011-05134, 2050012-2011-05135, 2050012-2011-05136, 2050012-2011-05137.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BECKMAN COULTER, INC. (BCI) TO REPORT THAT THEIR UNICEL DXC 600 SYNCHRON CLINICAL SYSTEM GAVE ERRONEOUS SODIUM (NA), POTASSIUM (K), CHLORIDE (CL), CARBON DIOXIDE (CO2) AND CALCIUM (CALC) RESULTS FOR TEN PATIENT SAMPLES. THE ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY. IT IS UNKNOWN IF THERE WERE ANY CHANGES TO PATIENT TREATMENT AS A RESULT OF THIS EVENT. THERE WERE NO REPORTS OF DEATH OR SERIOUS INJURY. THE CUSTOMER STATED THAT THE WEEKLY ALTERNATE FLOW CELL CLEANING PROCEDURE WAS PERFORMED ON THIS SYSTEM. FOLLOWING THE CLEANING, THE ION SELECTIVE ELECTRODE (ISE) SYSTEM WAS CALIBRATED AND A QUALITY CONTROL (QC) WAS RUN. THE QC RESULTS WERE WITHIN THE LAB'S ESTABLISHED RANGES. APPROXIMATELY ONE TO THREE HOURS AFTER THE CLEANING, THE OPERATOR NOTICED NEGATIVE ANION GAPS. A QC WAS PERFORMED AND THE NA RESULT WAS 2 STANDARD DEVIATIONS (SD) LOW. THE ISE SYSTEM WAS CALIBRATED AND THE NA QC WAS 3 SD LOW. ANOTHER CALIBRATION WAS DONE AND THE QC RESULTS WERE WITHIN THE LAB'S ESTABLISHED RANGES. ALL SAMPLES SINCE THE PREVIOUSLY ACCEPTABLE QC WERE REPEATED. AMENDED REPORTS WERE ISSUED ON TEN PATIENT SAMPLES. THIS IS REPORT 1 OF 10 MEDWATCH REPORTS FOR PATIENT 1 OF 10 PATIENTS.

    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