BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 800 SYNCHRON SYSTEM

    MDR report key: 2252806 · Received September 9, 2011

    Report

    Report Number
    2050012-2011-05232
    Event Type
    Malfunction
    Date Received
    September 9, 2011
    Date of Event
    December 30, 2008
    Report Date
    December 30, 2008
    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
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO SERVICE CALL WAS REQUESTED OR INITIATED. ACCORDINGLY, A FULL EXAMINATION OF THE SYSTEM WAS NOT PERFORMED. THE CUSTOMER WAS INSTRUCTED TO CLEAN THE SODIUM ELECTRODE AND BEGIN USING THE OPTIONAL TWICE WEEKLY FLOW CELL CLEANING PROCEDURE. ALTHOUGH THIS MEASURE MAY HAVE RESOLVED THE PROBLEM, A CLEAR ROOT CAUSE COULD NOT BE DETERMINED; ACCORDINGLY NO CONCLUSION CAN BE DRAWN. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS CONDUCTED BETWEEN (B)(6) 2008 AND (B)(6) 2010 FOR ADDITIONAL REPORTABLE EVENTS. THIS IS ONE OF FIFTY (50) MEDWATCH REPORTS BEING SUBMITTED AS THE CUSTOMER REPORTED FIFTY INDIVIDUAL PT RESULTS WERE AFFECTED. REFERENCE THE BELOW MDR NUMBERS FOR ALL ASSOCIATED EVENTS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT APPROX FIFTY (50) ERRONEOUS SODIUM (NA) RESULTS WERE GENERATED BY THE UNICEL DXC 800 SYNCHRON SYSTEM ONE DAY FOLLOWING A WEEKLY MAINTENANCE PROCEDURE. THE RESULTS WERE REPORTED OUT OF THE LAB. THE OPERATOR DETECTED THE LOW RESULTS BY MONITORING ANION GAPS. ALL SAMPLES WITH LOW NA RESULTS WERE REPEATED ON THE LAB'S SECOND DXC800. THE REPEAT RESULTS WERE HIGHER AND WITHIN EXPECTATION. AMENDED REPORTS WERE ISSUED. IT IS NOT KNOWN IF THERE WERE ANY CHANGES TO THE CARE OR TREATMENT OF HT PT. 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 800 SYNCHRON SYSTEM JGS BECKMAN COULTER, INC NA NA

    Patients

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