BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNICEL DXC 600 SYNCHRON CLINICAL SYSTEM

    MDR report key: 2183686 · Received July 22, 2011

    Report

    Report Number
    2050012-2011-03338
    Event Type
    Injury
    Date Received
    July 22, 2011
    Date of Event
    March 6, 2008
    Report Date
    March 6, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JGS
    PMA / PMN Number
    K042291
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TROUBLESHOOTING OF THE UNIT WAS PERFORMED BY THE CUSTOMER AND A FIELD SERVICE ENGINEER (FSE) VIA TELEPHONE. A CLEAR ROOT CAUSE FOR THIS EVENT HAS NOT YET BEEN DETERMINED TO DATE, ALTHOUGH THIS EVENT APPEARS TO BE CONNECTED TO PERFORMING THE WEEKLY ION SELECTIVE ELECTRODE (ISE) MAINTENANCE PROCEDURE. THE CUSTOMER HAS BEEN PROVIDED WITH AN ALTERNATE WEEKLY VALIDATED ISE MAINTENANCE PROCEDURE TO MINIMIZE POTENTIAL ISE DRIFT. 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 MDR REPRESENTS EVENT 13 OF 25 REPORTED BY THIS CUSTOMER. THIS MDR IS RELATED TO THE FOLLOWING MDRS THAT HAVE BEEN REPORTED: 2050012-2011-03297, 03300, 03301, 03302, 03303, 03304, 03307, 03328, 03329, 03331, 03334, 03336, 03340, 03343, 03345, 03346, 03349, 03351, 03353, 03354, 03355, 03356, 03357, 03358.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BECKMAN COULTER, INC (BCI) TO REPORT THAT AFTER PERFORMING WEEKLY MAINTENANCE ON THEIR UNICEL DXC 600 SYNCHRON CLINICAL SYSTEM, THE SYSTEM OBTAINED ERRONEOUSLY LOW RESULTS FOR SODIUM (NA) AND CALCIUM (CALC) AND ERRONEOUSLY HIGH RESULTS FOR CHLORIDE (CL) FOR 25 PATIENTS. THE ERRONEOUS TEST RESULTS WERE REPORTED OUTSIDE OF THE LAB. AN UNKNOWN NUMBER OF PATIENTS WERE REPORTED TO HAVE HAD CHANGES TO PATIENT TREATMENT AS A RESULT OF THIS EVENT. THE CUSTOMER STATED THAT THE QUALITY CONTROL (QC) RUN IMMEDIATELY AFTER THE MAINTENANCE OBTAINED RESULTS WITHIN THE RANGES ESTABLISHED BY THE LABORATORY. THE CUSTOMER FURTHER STATED THAT THEIR PROCEDURE IS TO CALIBRATE POTASSIUM (K) EVERY 8 HOURS AND RUN AN ADDITIONAL QC OF ALL ANALYTES. DURING THIS QC, IT WAS DISCOVERED THAT NA, CL AND CALC WERE OUTSIDE OF THE ESTABLISHED RANGES. THIS IS REPORT 13 OF 25 MEDWATCH REPORTS FILED FOR THIS EVENT FOR PATIENT 13 OF 25 PATIENTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention