BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 800 SYNCHRON CLINICAL SYSTEM

    MDR report key: 2121846 · Received May 20, 2011

    Report

    Report Number
    2050012-2011-01615
    Event Type
    Malfunction
    Date Received
    May 20, 2011
    Date of Event
    May 6, 2009
    Report Date
    May 6, 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
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE BECKMAN COULTER, INC. (BCI) FSE (FIELD SERVICE ENGINEER) BLEACHED THE ISE (ION-SELECTIVE ELECTRODE) SYSTEM FLOW CELL WHICH RESOLVED THE PROBLEM. BLEACHING IS NORMALLY USED FOR BACTERIAL CONTAMINATION AND WHILE THIS MAY HAVE ALLEVIATED THE PROBLEM, 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 800 INSTRUMENT, RESULTS WERE REPORTED OUT OF THE LABORATORY AND ONE PHYSICIAN QUESTIONED THE RESULTS OF SOME OF HIS PATIENTS. PRIOR TO THE EVENT, THE SYSTEM WAS CALIBRATED AND THE QC (QUALITY CONTROL) RESULTS WERE WITHIN THE LAB'S ESTABLISHED RANGES. THE CUSTOMER RE-RAN THE PATIENT SAMPLES ON ANOTHER DXC INSTRUMENT AND GOT VALUES WHICH WERE 5 MMOL/L POINTS HIGHER. THE CUSTOMER AMENDED THE RESULTS AND FILED CORRECTIVE REPORTS. THERE IS NO REPORT OF ANY ADVERSE EVENT OR SERIOUS INJURY RELATED TO THIS EVENT AND THERE WAS NO CHANGE TO PATIENT TREATMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK