BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL 800 SYNCHRON SYSTEM

    MDR report key: 2151620 · Received June 24, 2011

    Report

    Report Number
    2050012-2011-02233
    Event Type
    Malfunction
    Date Received
    June 24, 2011
    Date of Event
    May 4, 2009
    Report Date
    May 4, 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
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE BCI HOTLINE CUSTOMER SERVICE TECHNICIAN RECOMMENDED THAT THE CUSTOMER CLEAN THE ISE (ION-SELECTIVE ELECTRODE) FLOW CELL. WHILE THIS MEASURE MAY HAVE ALLEVIATED THE PROBLEM, A CLEAR ROOT CAUSE COULD NOT BE DETERMINED. THIS IS 1 OF 50 INDIVIDUAL MEDWATCH REPORTS WHICH ARE RELATED TO THIS EVENT. 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 IS ONE OF FIFTY SEPARATE MEDWATCH REPORTS BEING SUBMITTED AS THIS EVENT INVOLVES FIFTY SEPARATE PT EVENTS THAT WERE REPORTED OUT OF THE LABORATORY. SEE THE FOLLOWING REPORT NUMBERS FOR ALL ASSOCIATED EVENTS: 2050012-2011-01614, 02220, 02221, 02222, 02223, 02224, 02225, 02226, 02227, 02228, 02229, 02230, 02231, 02232, 02234, 02239, 02240, 02241, 02242, 02243, 02244, 02245, 02246, 02247, 02307, 02308, 02309, 02310, 02311, 02312, 02313, 02314, 02315, 02316, 02317, 02318, 02319, 02320, 02321, 02322, 02323, 02324, 02325, 02326, 02327, 02328, 02329, 02330, 02331.

    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 800 SYNCHRON INSTRUMENT AND THE RESULTS WERE REPORTED OUT OF THE LABORATORY. THE ISE (ION-SELECTIVE ELECTRODE) SYSTEM WAS ROUTINELY CALIBRATED EVERY 24 HOURS. PRIOR TO THE EVENT, THE QC (QUALITY CONTROL) RESULTS WERE WITHIN THE LAB'S ESTABLISHED RANGES. WHEN THE OPERATOR BECAME AWARE OF THE LOW NA RESULTS, THE OPERATOR RE-RAN THE PT SAMPLES ON THE LAB'S SECOND ANALYZER INSTRUMENT. THE REPEATED RESULTS WERE HIGHER (APPROXIMATELY 4-7 MMOL/L HIGHER) AND THE CUSTOMER AMENDED THE RESULTS AND FILED 50 CORRECTED REPORTS. A SAMPLING OF THE PT RESULTS (I.E. 10 OF THE 50 PT DATA POINTS) WAS PROVIDED BY THE CUSTOMER. WHILE THERE IS NO REPORT OF ANY ADVERSE EVENT OR SERIOUS INJURY RELATED TO THIS EVENT, IT IS UNK WHETHER THERE WAS ANY CHANGE TO PT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL 800 SYNCHRON SYSTEM JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK