BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON LX 20 PRO SYSTEM

    MDR report key: 2150458 · Received June 8, 2011

    Report

    Report Number
    2050012-2011-02004
    Event Type
    Malfunction
    Date Received
    June 8, 2011
    Date of Event
    June 2, 2009
    Report Date
    June 3, 2009
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JGS
    PMA / PMN Number
    K011213
    Removal / Correction Number
    Z-0863-2010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE BCI FSE (FIELD SVC ENGINEER) PERFORMED A PM (PREVENTATIVE MAINTENANCE) ON THE ISE (ION-SELECTIVE ELECTRODE) SYS. THE FSE REPLACED THE HIGH PRESSURE PUMP AND THE VACUUM PUMP. THE FSE FOUND A LARGE AMOUNT OF FUNGAL/BACTERIAL GROWTH IN THE HYDRO DI H2O (DEIONIZED WATER) CANISTERS (WHICH MAY CAUSE ISE INSTABILITY) AND DECONTAMINATED THE HYDRO CANISTERS AND THE ISE FLOW CELL. THE ISE SYS WAS PRIMED, CONDITIONED AND CALIBRATED AND THE QC RESULTS STABLE AND WITHIN EXPECTED RANGES. WHILE THESE MEASURES MAY HAVE RESOLVED THE PROBLEM, A CLEAR ROOT CAUSE COULD NOT BE DETERMINED. THIS IS 1 OF 40 INDIVIDUAL MEDWATCH REPORTS WHICH ARE RELATED TO THIS EVENT. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS CONDUCTED BETWEEN JANUARY 1, 2008 TO OCTOBER 23, 2010 FOR ADD'L REPORTABLE EVENTS. THIS IS ONE OF FORTY SEPARATE MEDWATCH REPORTS BEING SUBMITTED AS THIS EVENT INVOLVES FORTY SEPARATE PT EVENTS THAT WERE REPORTED OUT OF THE LABORATORY. SEE THE FOLLOWING REPORT NUMBERS FOR ALL ASSOCIATED EVENTS: 2050012-2011-01619, 01983, 01984, 01985, 01986, 01987, 01988, 01989, 01990, 01991, 01992, 01993, 01994, 01995, 01996, 01997, 01998, 01999, 02000, 02001, 02002, 02003, 02005, 02006, 02007, 02008, 02009, 02010, 02011, 02012, 02013, 02014, 02015, 02016, 02017, 02018, 02019, 02020, 02021.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BCI) THAT ERRONEOUSLY LOW SODIUM (NA) RESULTS WERE OBTAINED ON THEIR SYNCHRON LX 20 PRO INSTRUMENT, RESULTS WERE REPORTED OUT OF THE LABORATORY AND THAT THIS HAD BEEN A PREVIOUS INTERMITTENT ISSUE FOR APPROX 2 MONTHS. PRIOR TO EACH EVENT, THE QC (QUALITY CONTROL) RESULTS WERE WITHIN THE LAB'S ESTABLISHED RANGES. IN EACH INSTANCE, WHEN THE OPERATOR BECAME AWARE OF THE LOW NA RESULTS, THE OPERATOR RE-VISITED SPECIMENS THAT WERE RUN EARLIER AND RE-RAN THE PT SAMPLES ON THE LAB'S SECOND ANALYZER INSTRUMENT. THE REPEATED RESULTS WERE HIGHER (10-15% INCREASED RECOVERY), AND THE CUSTOMER AMENDED THE RESULTS AND FILED 40 CORRECTED REPORTS. NO SAMPLE OR PT INFO WAS PROVIDED BY THE CUSTOMER. THE TOTAL NUMBER OF SAMPLES ANALYZED IS UNK. 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 PT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON LX 20 PRO SYSTEM JGS BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK