BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 600 SYNCHRON SYSTEM

    MDR report key: 2151522 · Received June 24, 2011

    Report

    Report Number
    2050012-2011-02462
    Event Type
    Malfunction
    Date Received
    June 24, 2011
    Date of Event
    August 29, 2009
    Report Date
    August 29, 2009
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JGS
    PMA / PMN Number
    K042291
    Removal / Correction Number
    Z-0863-2010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE BCI HOTLINE SENT THE LABORATORY THE OPTIONAL TWICE-WEEKLY FLOW CELL CLEANING PROCEDURE WHICH INCLUDES BLEACH AS A CLEANING AGENT, SINCE THE OPERATOR ON DUTY WAS NOT AWARE OF THE PROCEDURE. ADDITIONALLY, A BCI ENGINEER PROVIDED SERVICE TO THE CUSTOMER OVER THE PHONE BY GIVING THEM INSTRUCTIONS FOR TROUBLESHOOTING AND REPAIRS. WHILE THESE MEASURES MAY HAVE ALLEVIATED THE PROBLEM, A CLEAR ROOT CAUSE WAS NOT IDENTIFIED. THIS IS ONE OF TEN INDIVIDUAL MEDWATCH REPORTS RELATED TO THE SAME EVENT. THE RELATED MDRS ARE AS FOLLOWS: 2050012-2011-02446, 02461, 02463, 02464, 02465, 02466, 02467, 02468 AND 02469. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS CONDUCTED BETWEEN JAN 1, 2008 TO OCTOBER 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 THE UNICEL DXC 600 SYNCHRON INSTRUMENT. PRIOR TO THE EVENT, THE ISE (ION-SELECTIVE ELECTRODE) SYSTEM WAS CALIBRATED AND THE NA QC (QUALITY CONTROL) RESULTS WERE WITHIN THE LAB'S ESTABLISHED RANGES. PHYSICIANS CONTACTED THE LABORATORY AND QUESTIONED THE LOW RESULTS. THE CUSTOMER RE-CALIBRATED THE ISE SYSTEM AND RAN QC (QUALITY CONTROL) WHICH WAS WITHIN RANGE. THE CUSTOMER RE-RAN THE PT SAMPLES AND THE NA RECOVERED HIGHER. AMENDED REPORTS WERE ISSUED ON 10 PT SAMPLES. NO PT OR SAMPLE DATA WERE PROVIDED. 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 MGMT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK