BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 600 SYNCHRON CLINICAL SYSTEM

    MDR report key: 2172534 · Received June 24, 2011

    Report

    Report Number
    2050012-2011-02552
    Event Type
    Malfunction
    Date Received
    June 24, 2011
    Date of Event
    December 30, 2009
    Report Date
    December 30, 2009
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    Z-0863-2010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A BCI FSE (FIELD SVC ENGINEER) WAS DISPATCHED TO THE SITE AND PERFORMED TROUBLESHOOTING. THE FSE CLEANED THE ISE (ION-SELECTIVE ELECTRODE) FLOW CELL AND REPLACED SEVERAL ISE HARDWARE COMPONENTS. THE CUSTOMER HAS BEEN USING THE AUTOMATED WEEKLY FLOW CELL MAINTENANCE PROCEDURE AND THEY WERE PROVIDED WITH THE TWICE-WEEKLY FLOW CELL CLEANING AND MAINTENANCE PROCEDURE. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. THIS IS 1 OF 3 MEDWATCHES RELATED TO THIS EVENT. THE RELATED MEDWATCHES ARE LISTED BELOW: 2050012-2010-00014, 2050012-2011-02549. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS CONDUCTED BETWEEN 1/1/2008 AND 10/23/2010 FOR ADD'L REPORTABLE EVENTS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BECKMAN COULTER, INC (BCI) THAT ERRONEOUSLY LOW SODIUM (NA) RESULTS WERE OBTAINED ON THEIR UNICEL DXC 600 SYNCHRON INSTRUMENT, THE RESULTS WERE REPORTED OUT OF THE LAB AND THAT THIS HAD BEEN A PREVIOUS INTERMITTENT ISSUE WHICH OCCURRED ABOUT 2 WEEKS PRIOR TO THE REPORT OF THIS EVENT. THE ISE (ION-SELECTIVE ELECTRODE) SYS WAS NORMALLY CALIBRATED EVERY 24 HOURS AND THE QC (QUALITY CONTROL) RUNS PERFORMED AT THAT TIME. PRIOR TO AND FOLLOWING EACH EVENT, THE QC RESULTS HAVE BEEN WITHIN THE LAB'S ESTABLISHED RANGES. WHEN PHYSICIANS QUESTIONED THE LOW RESULTS, THE CUSTOMER RE-RAN THE PT SAMPLES ON A DIFFERENT ANALYZER, FOUND THAT THE RESULTS WERE HIGHER AND ISSUED AMENDED REPORTS. THE CUSTOMER PROVIDED 3 EXAMPLES OF THE ERRONEOUSLY LOW NA RESULTS ALONG WITH THE CORRECTED RESULTS. NO DATA WAS PROVIDED FROM THE INCIDENT THAT OCCURRED 2 WEEKS EARLIER. THE TOTAL NUMBER OF PT SAMPLE RESULTS REPORTED OUT OF THE LAB IS UNK. WHILE THE CUSTOMER DID NOT RECEIVE ANY REPORT OF ANY ADVERSE EVENT OR INJURY ASSOCIATED WITH THIS EVENT, IT IS UNK IF THERE WAS ANY CHANGE TO PT TREATMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR