BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 600 SYNCHRON SYSTEM

    MDR report key: 2229243 · Received August 12, 2011

    Report

    Report Number
    2050012-2011-04390
    Event Type
    Malfunction
    Date Received
    August 12, 2011
    Date of Event
    August 25, 2010
    Report Date
    August 25, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JGS
    PMA / PMN Number
    K042291
    Removal / Correction Number
    Z-0863-2010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) VISITED THE FACILITY AND EXAMINED THE SYSTEM. NO CULTURES OF THE SYSTEM WERE TAKEN OR PROVIDED. THE FSE DECONTAMINATED THE SYSTEM. THERE WERE NO FURTHER REPORTS BY THE CUSTOMER OF ISSUES AS OF 09/14/2010. ALTHOUGH THE SYSTEM WAS DECONTAMINATED AND THIS MEASURE MAY HAVE RESOLVED THE PROBLEM, A CLEAR ROOT CAUSE COULD NOT BE DETERMINED; ACCORDINGLY NO CONCLUSION CAN BE DRAWN. THIS IS 1 OF 9 MEDWATCH REPORTS BEING SUBMITTED AS THIS EVENT OCCURRED ON 9 SEPARATE DATES. REFERENCE THE BELOW MDR NUMBERS FOR ALL ASSOCIATED EVENTS. MDR #2010012-2010-00813, 2050012-2011-04381, 04382, 04383, 04384, 04385, 04386, 04389. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS CONDUCTED BETWEEN JANUARY 1, 2008 AND OCTOBER 23, 2010 FOR ADDITIONAL REPORTABLE EVENTS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT ERRONEOUSLY LOW SODIUM, CHLORIDE AND ANION GAP RESULTS WERE GENERATED BY THE UNICEL DXC 600 SYNCHRON SYSTEM. THE RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. QUALITY CONTROLS WERE WITHIN SPECIFICATION PRIOR TO THE EVENT. THE OPERATOR NOTED THE LOW ANION GAPS, RETESTED THE SAMPLES ON ANOTHER SYSTEM AND OBTAINED RESULTS WITHIN EXPECTATION. THE RESULTS FROM THE RETESTING WERE REPORTED OUT OF THE LABORATORY. THERE ARE NO REPORTS OF ANY ADVERSE EVENTS OR NEED FOR MEDICAL INTERVENTION TO PREVENT OR PRECLUDE SERIOUS INJURY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ISE ELECTROLYTE REFERENCE| ISE ELECTROLYTE BUFFER