BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 600 SYNCHRON CLINICAL SYSTEM

    MDR report key: 2121858 · Received May 20, 2011

    Report

    Report Number
    2050012-2011-01613
    Event Type
    Malfunction
    Date Received
    May 20, 2011
    Date of Event
    April 23, 2009
    Report Date
    April 23, 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
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    RECALIBRATION OF THE SYSTEM ALLEVIATED THE PROBLEM. AN FSE (FIELD SERVICE ENGINEER) PERFORMED THE FLOW CELL CLEANING PROCEDURE. FOREIGN MATERIAL CONTAMINATION WAS PRESENT. THE ISE (ION-SELECTIVE ELECTRODE) FLOW CELL WAS FOUND TO BE CONTAMINATED WITH BACTERIA WHICH MAY HAVE CONTRIBUTED TO THE ERROR BUT A CLEAR ROOT CAUSE COULD NOT BE DETERMINED. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS CONDUCTED BETWEEN (B)(6) 2008 TO (B)(6) 2010 FOR ADDITIONAL REPORTABLE EVENTS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BCI) THAT ERRONEOUSLY LOW SODIUM (NA) RESULTS WERE OBTAINED ON THEIR UNICEL DXC 600 INSTRUMENT. THE CUSTOMER RAN THE PATIENT SAMPLES ON ANOTHER DXC 600 INSTRUMENT AND GOT VALUES THAT MATCHED THE FIRST SET OF VALUES. THE RESULTS WERE REPORTED OUT. ONE PHYSICIAN CALLED THE LABORATORY AND ASKED THAT THE INSTRUMENTS BE RECALIBRATED AND PATIENT SAMPLES RERUN. CALIBRATION WAS PERFORMED AND THE QC (QUALITY CONTROL) WAS RUN AGAIN AND FOUND TO BE WITHIN THE LAB'S ESTABLISHED RANGES. CUSTOMER THEN RE-RAN PATIENT SAMPLES AND DISCOVERED THAT THE NA RESULTS WERE HIGHER AND IN THE NORMAL RANGE. THE PATIENT RESULTS WERE AMENDED. RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. WHILE THERE IS NO REPORT OF ANY ADVERSE EVENT OR SERIOUS INJURY RELATED TO THIS EVENT, IT IS UNKNOWN WHETHER THERE WAS ANY MODIFICATION TO PATIENT TREATMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK