BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 600I SYNCHRON SYSTEM

    MDR report key: 2161045 · Received June 17, 2011

    Report

    Report Number
    2050012-2011-02353
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    November 19, 2008
    Report Date
    November 19, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K060256
    Removal / Correction Number
    Z-0863-2010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE BCI FSE (FIELD SERVICE ENGINEER) PERFORMED TROUBLESHOOTING AT THE SITE ON THE ISE (ION-SELECTIVE ELECTRODE) SYSTEM. THE FSE CULTURED THE ISE SYSTEM AND FOUND THAT IT WAS POSITIVE FOR BACTERIAL GROWTH. THE ISE SYSTEM WAS DECONTAMINATED AND THE FOLLOWING MAINTENANCE PROCEDURES WERE COMPLETED: CL TIP WAS REPLACED, NA ELECTRODES WERE REPLACED, CARBON BRIDGE WAS REPLACED, THE RATIO PUMP WAS REBUILT AND THE EIC (ELECTROLYTE INJECTION CUP) ASSEMBLY WAS CLEANED. WHILE THESE MEASURES MAY HAVE RESOLVED THE PROBLEM, A CLEAR ROOT CAUSE COULD NOT BE DETERMINED. THIS IS 1 OF 5 INDIVIDUAL MEDWATCH REPORTS WHICH ARE RELATED TO THIS EVENT. THE RELATED MDRS ARE AS FOLLOWS: 2050012-211-02180, 2050012-2011-02354, 2050012-2011-02355, 2050012-2011-02356. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS CONDUCTED BETWEEN (B)(4) 2008 TO (B)(4) 2010 FOR ADDITIONAL REPORTABLE EVENTS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BCI) THAT ERRONEOUSLY LOW SODIUM (NA) AND LOW CHLORINE (CL) RESULTS WERE OBTAINED ON THEIR UNICEL DXC 600I SYNCHRON INSTRUMENT, RESULTS WERE REPORTED OUT OF THE LABORATORY AND THAT THIS HAD BEEN A PREVIOUS INTERMITTENT ISSUE WHICH RECURRED APPROXIMATELY EVERY 2 MONTHS. PRIOR TO EACH EVENT, THE ISE (ION-SELECTIVE ELECTRODE) SYSTEM WAS SUCCESSFULLY CALIBRATED AND THE QC (QUALITY CONTROL) RESULTS WERE WITHIN THE LAB'S ESTABLISHED RANGES. IN EACH INSTANCE, WHEN THE OPERATOR BECAME AWARE OF THE LOW NA AND CL RESULTS, THE OPERATOR RE-VISITED SPECIMENS THAT WERE RUN EARLIER AND RE-RAN THE PATIENT SAMPLES. THE REPEATED RESULTS WERE HIGHER AND THE CUSTOMER AMENDED THE RESULTS AND FILED CORRECTED REPORTS. A SAMPLING (I.E. 5 PATIENT DATA POINTS) SHOWING THE LOW NA AND CL RESULTS ALONG WITH THE REPEATED RESULTS WERE PROVIDED BY THE CUSTOMER. THE TOTAL NUMBER OF SAMPLES ANALYZED IS UNKNOWN. THERE IS NO REPORT OF ANY ADVERSE EVENT OR SERIOUS INJURY RELATED TO THIS EVENT. HOWEVER, IT IS NOT KNOWN WHETHER THERE WAS ANY CHANGE TO PATIENT TREATMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK