BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 600 SYNCHRON SYSTEM

    MDR report key: 2142182 · Received May 26, 2011

    Report

    Report Number
    2050012-2011-01472
    Event Type
    Malfunction
    Date Received
    May 26, 2011
    Date of Event
    August 8, 2009
    Report Date
    August 12, 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
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BCI FSE (FIELD SERVICE ENGINEER) PROVIDED SERVICE TO THE ISE SYSTEM. THE FSE REPLACED THE CL ELECTRODE, REMOVED A SUBSTANCE RESEMBLING GLUE IN THE K PORT AND CLEANED THE FLOW CELL AND THIS ALLEVIATED THE PROBLEM. THE LABORATORY USES THE OPTIONAL TWICE-WEEKLY FLOW CELL CLEANING PROCEDURE WHICH INCLUDES BLEACH AS A CLEANING AGENT. THIS IS ONE OF SIXTEEN INDIVIDUAL MEDWATCH REPORTS RELATED TO THE SAME EVENT WHICH INVOLVED MULTIPLE UNKNOWN PATIENT RESULTS. THE RELATED MDRS ARE AS FOLLOWS: 2050012-2011-01471, 01473, 01474, 01475, 01480, 01481, 01482, 01483, 01484, 01485, 01486, 01487, 01488, 01489, 01490. 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 ERRONEOUSLY LOW SODIUM (NA), CHLORINE (CL) AND CALCIUM (CA) RESULTS WERE OBTAINED OUT OF RANGE LOW ON THE UNICEL DXC 600 SYNCHRON INSTRUMENT SINCE (B)(6) 2009, AND THE OPERATOR HAD CONTINUED TO RUN PATIENT SAMPLES AND REPORTED THE RESULTS OUT OF THE LABORATORY. PHYSICIANS CONTACTED THE LABORATORY AND QUESTIONED THE LOW RESULTS. IT IS NOT KNOWN THE TOTAL NUMBER OF PATIENT SAMPLES REPORTED OUT OF THE LABORATORY. THE CUSTOMER RE-CALIBRATED THE ISE (ION-SELECTIVE ELECTRODE) SYSTEM ON ANOTHER DXC INSTRUMENT AND RAN QC (QUALITY CONTROL) WHICH WAS WITHIN RANGE. THE CUSTOMER RE-RAN THE PATIENT SAMPLES AND THE NA RECOVERED 7 MMOL/L POINTS HIGHER. AMENDED REPORTS WERE ISSUED ON 16 PATIENT SAMPLES. WHILE THERE IS NO REPORT OF ADVERSE EVENT OR SERIOUS INJURY RELATED TO THIS EVENT, IT IS UNKNOWN WHETHER THERE WAS ANY CHANGE TO PATIENT MANAGEMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK