BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 SYNCHRON® SYSTEM

    MDR report key: 3251158 · Received July 29, 2013

    Report

    Report Number
    2050012-2013-00506
    Event Type
    Malfunction
    Date Received
    July 29, 2013
    Date of Event
    July 9, 2013
    Report Date
    July 10, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    JGS
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS NOT DISPATCHED TO THE CUSTOMER'S SITE FOR THIS EVENT. A BECKMAN COULTER CUSTOMER TECHNICAL SUPPORT (CTS) ASSISTED THE CUSTOMER WITH TROUBLESHOOTING OVER THE PHONE. THE CTS RECOMMENDED THAT THE CUSTOMER REPLACE THE MODULAR CHEMISTRY (MC) SAMPLE SYRINGE IF THE SYRINGE APPEARED DISCOLORED, FLUSH THE MC SAMPLE PROBE, AND REPLACE THE CO2 ELECTRODE MEMBRANE. UPON FOLLOW-UP, THE CUSTOMER REPORTED REPLACING THE MC SAMPLE SYRINGE, EVEN THOUGH THERE WAS NO DISCOLORATION, AND THE CO2 MEMBRANE WHICH APPEARED WORN. THE CUSTOMER PERFORMED PRECISION RUNS TO VERIFY REPAIRS AND RESULTS PASSED WITHIN SPECIFICATIONS. FAILURE MODE FOR THE EVENT IS UNKNOWN; THE CUSTOMER REPLACED THE CO2 MEMBRANE AND MC SAMPLE SYRINGE WHICH RESOLVED THE ISSUE. ALL RELATED MEDWATCH REPORTS ASSOCIATED WITH THIS EVENT: 2050012-2013-00506, 2050012-2013-00507. ISSUE WAS RESOLVED BY THE CUSTOMER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED OBTAINING ERRONEOUSLY HIGH ION SELECTIVE ELECTRODE (ISE) RESULTS FOR TWO (2) PATIENTS, OVER SEPARATE DAYS, INVOLVING THE UNICEL DXC 800 SYNCHRON SYSTEM. THIS REPORT REFERENCES THE EVENT WHICH OCCURRED ON (B)(6) 2013. PLEASE REFER TO MEDWATCH REPORT #2050012-2013-00507 FOR THE REPORT OF THE EVENT WHICH OCCURRED ON (B)(6) 2013. THE CUSTOMER REPORTED GENERATED ERRONEOUSLY HIGH SODIUM (NA) AND CARBON DIOXIDE (CO2) RESULTS FOR ONE (1) PATIENT SAMPLE. WHEN THE ISSUE WAS NOTICED, THE CUSTOMER REPEATED THE SAMPLE ON AN ALTERNATE DXC ANALYZER AS WELL AS ON THE ORIGINAL DXC ANALYZER AFTER RECALIBRATION; AN AMENDED REPORT WAS ISSUED AND THERE WAS NO CHANGE OR AFFECT TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT. NA AND CHLORIDE (CL) QUALITY CONTROL (QC) RESULTS WERE WITHIN THE LABORATORY'S ESTABLISHED RANGES PRIOR TO AND FOLLOWING THE HIGH RESULTS. HOWEVER, CO2 QC EXHIBITED IMPRECISION AND HIGH RECOVERY AT GREATER THAN 2 STANDARD DEVIATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352750 UNICEL® DXC 800 SYNCHRON® SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JGS BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR