BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC SYNCHRON CLINICAL SYSTEM

    MDR report key: 2171244 · Received July 1, 2011

    Report

    Report Number
    2050012-2011-02556
    Event Type
    Malfunction
    Date Received
    July 1, 2011
    Date of Event
    December 18, 2009
    Report Date
    December 18, 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
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A BCI FSE (FIELD SERVICE ENGINEER) WAS NOT DISPATCHED TO THE SITE SINCE ONE WAS REQUESTED BY THE CUSTOMER. THE BCI HOTLINE PROVIDED THE CUSTOMER WITH THE TWICE-WEEKLY FLOW CELL MAINTENANCE PROCEDURE. THE CUSTOMER CLEANED THE ISE FLOW CELL AND THIS RESOLVED THE PROBLEM. HOWEVER, A DEFINITIVE ROOT CAUSE WAS NOT DETERMINED. THIS IS ONE OF SIX SEPARATE MEDWATCH REPORTS RELATED TO THIS EVENT. ALL ASSOCIATED REPORTS ARE LISTED BELOW: 2050012-2010-00001, 2050012-2011-02551, 2050012-2011-02555, 2050012-2011-02557, 2050012-2011-02558. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS CONDUCTED FROM (B)(4), 2008 THOUGH (B)(4), 2010 FOR ADDITIONAL REPORTABLE EVENTS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE BECKMAN COULTER, INC (BCI) THAT ERRONEOUSLY LOW SODIUM (NA) AND CALCIUM (CA) RESULTS WERE OBTAINED ON THEIR UNICEL DXC 600 INSTRUMENT AND THE RESULTS WERE REPORTED OUT OF THE LABORATORY. PRIOR TO THE EVENT, THE ISE (ION-SELECTIVE ELECTRODE) SYSTEM WAS CALIBRATED AND QC (QUALITY CONTROL) RESULTS WERE FOUND TO BE OUTSIDE THE LAB'S ESTABLISHED RANGES. THE QC RUNS FOR NA AND CA WERE IMMEDIATELY REPEATED AND FOUND TO BE WITHIN THE ACCEPTABLE RANGES BUT AT THE LOW END OF THE RANGES. SAMPLES WERE ANALYZED AND SEVERAL LOW NA AND CA RESULTS WERE REPORTED OUT OF THE LAB. THE CUSTOMER RE-RAN THE PATIENT SAMPLES, FOUND THE RESULTS WERE HIGHER AND ISSUED AMENDED REPORTS. THE LAB WAS USING THE AUTOMATED WEEKLY FLOW CELL CLEANING PROCEDURE. THE CUSTOMER PROVIDED SIX EXAMPLES OF THE ERRONEOUSLY LOW RESULTS ALONG WITH THE CORRECTED RESULTS. THE TOTAL NUMBER OF PATIENT SAMPLE RESULTS REPORTED OUT OF THE LABORATORY IS UNKNOWN. WHILE THE CUSTOMER DID NOT RECEIVE ANY REPORT OF ANY ADVERSE EVENT OR PATIENT INJURY ASSOCIATED WITH THIS EVENT, IT IS NOT KNOWN IF THERE WAS ANY CHANGE TO PATIENT TREATMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR