BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 800 SYNCHRON SYSTEM

    MDR report key: 2211564 · Received August 5, 2011

    Report

    Report Number
    2050012-2011-04115
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Date of Event
    June 15, 2008
    Report Date
    June 16, 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
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO SERVICE CALL OR EVALUATION OF THE SYSTEM WAS PERFORMED. THE CUSTOMER RE-CALIBRATES THE SYSTEM UPON NOTICING ERRONEOUS ANION GAPS AND THEN RESUMES NORMAL OPERATION. ANION GAP VALUES OUTSIDE THE INTERVAL OF 7 TO 16 MMOL/L SUGGEST THE POSSIBILITY OF AN ERROR IN MEASUREMENT OF ONE OF THE ELECTROLYTES. ALTHOUGH THIS ACTION TEMPORARILY RESOLVES THE ISSUE, WITHOUT AN EXAMINATION OF THE SYSTEM A SPECIFIC ROOT CAUSE OF THIS EVENT CANNOT BE DETERMINED; ACCORDINGLY, NO CONCLUSION CAN BE DRAWN. 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

    CUSTOMER REPORTED THAT ERRONEOUSLY LOW SODIUM AND ANION GAPS WERE GENERATED BY THE UNICEL DXC 800 SYNCHRON SYSTEM. THE CALIBRATION AND QUALITY CONTROLS WERE WITHIN SPECIFICATION AFTER THE WEEKLY MAINTENANCE PROCEDURE AND PRIOR TO THE EVENT. THE CUSTOMER MONITORS RESULT ANION GAPS AND OBSERVED THE SUSPECTED ERRONEOUS RESULTS; THE RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. THE CUSTOMER RECALIBRATED THE SYSTEM, RAN QUALITY CONTROLS AND RESUMED NORMAL OPERATION. THE SAMPLES WERE RETESTED ON THE FACILITY'S OTHER SYSTEM AND REPEATED ON THE SAME SYSTEM AFTER MAINTENANCE. THE RESULTS OF THE RETEST WERE WITHIN EXPECTATIONS. THERE ARE NO REPORTS OF ANY ADVERSE EVENTS OR NEED FOR MEDICAL INTERVENTION TO PREVENT OR PRECLUDE SERIOUS INJURY.

    Additional Manufacturer Narrative · 2

    NO SERVICE CALL OR EVALUATION OF THE SYSTEM WAS PERFORMED. THE CUSTOMER RE-CALIBRATES THE SYSTEM UPON NOTICING ERRONEOUS ANION GAPS AND THEN RESUMES NORMAL OPERATION. ANION GAP VALUES OUTSIDE THE INTERVAL OF 7 TO 16 MMOL/L SUGGEST THE POSSIBILITY OF AN ERROR IN MEASUREMENT OF ONE OF THE ELECTROLYTES. ALTHOUGH THIS ACTION TEMPORARILY RESOLVES THE ISSUE, WITHOUT AN EXAMINATION OF THE SYSTEM A SPECIFIC ROOT CAUSE OF THIS EVENT CANNOT BE DETERMINED; ACCORDINGLY, NO CONCLUSION CAN BE DRAWN. 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 · 2

    CUSTOMER REPORTED THAT ERRONEOUSLY LOW SODIUM AND ANION GAPS WERE GENERATED BY THE UNICEL DXC 800 SYNCHRON SYSTEM. THE CALIBRATION AND QUALITY CONTROLS WERE WITHIN SPECIFICATION AFTER THE WEEKLY MAINTENANCE PROCEDURE AND PRIOR TO THE EVENT. THE CUSTOMER MONITORS RESULT ANION GAPS AND OBSERVED THE SUSPECTED ERRONEOUS RESULTS; THE RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. THE CUSTOMER RECALIBRATED THE SYSTEM, RAN QUALITY CONTROLS AND RESUMED NORMAL OPERATION. THE SAMPLES WERE RETESTED ON THE FACILITY'S OTHER SYSTEM AND REPEATED ON THE SAME SYSTEM AFTER MAINTENANCE. THE RESULTS OF THE RETEST WERE WITHIN EXPECTATIONS. 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 62 YR ISE ELECTROLYTE BUFFER:| ISE ELECTROLYTE REFERENCE:
    2 52 YR ISE ELECTROLYTE REFERENCE:| ISE ELECTROLYTE BUFFER: