BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 600 SYNCHRON CLINICAL SYSTEM

    MDR report key: 2142197 · Received May 26, 2011

    Report

    Report Number
    2050012-2011-01620
    Event Type
    Malfunction
    Date Received
    May 26, 2011
    Date of Event
    July 1, 2009
    Report Date
    July 15, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE BECKMAN COULTER, INC. (BCI) FSE (FIELD SERVICE ENGINEER) REPLACED THE CARBON BRIDGE AND WHILE THIS RESOLVED THE PROBLEM, A CLEAR ROOT CAUSE COULD NOT BE DETERMINED. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS CONDUCTED BETWEEN (B)(4) 2008 TO (B)(4) 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 BEING GENERATED ON THEIR UNICEL DXC 600 INSTRUMENT OVER A PERIOD OF ABOUT 3 MONTHS. PRIOR TO EACH EVENT, THE QC (QUALITY CONTROL) RESULTS WERE WITHIN THE LAB'S ESTABLISHED RANGES. THE CUSTOMER INDICATED THAT A PM (PREVENTATIVE MAINTENANCE) WAS CONDUCTED ON (B)(6) 2009 WHICH DID NOT CORRECT THE PROBLEM. CUSTOMER INDICATED THAT MULTIPLE PT RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THERE IS NO REPORT OF ANY ADVERSE EVENT OR SERIOUS INJURY RELATED TO THIS EVENT BUT IT IS NOT KNOWN IF THERE WAS ANY CHANGE TO PT 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