BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 600 SYNCHRON SYSTEM

    MDR report key: 2142186 · Received May 26, 2011

    Report

    Report Number
    2050012-2011-01649
    Event Type
    Malfunction
    Date Received
    May 26, 2011
    Date of Event
    November 13, 2009
    Report Date
    November 17, 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
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A BSI FSE (FIELD SVC ENGINEER) WAS DISPATCHED TO THE SITE TO TROUBLESHOOT AND REPLACED SEVERAL HARDWARE COMPONENTS (E.G NA ELECTRODE, NA REFERENCE ELECTRODE, CL ELECTRODE AND THE SAMPLE PROBE), HOWEVER, NO CLEAR ROOT CAUSE WAS DETERMINED. THIS IS ONE INDIVIDUAL MDR REPORT WHICH INCLUDES ONE PT RESULT PRESENTED AND ACCOUNTS FOR MULTIPLE UNK PT RESULTS. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS CONDUCTED BETWEEN 01/012008 TO 10/23/2010 FOR ADDITIONAL REPORTABLE EVENTS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO BECKMAN COULTER, INC (BCI) THAT ERRONEOUSLY LOW SODIUM (NA) RESULTS WERE INTERMITTENTLY OBTAINED ON THEIR UNICEL DXC 600 INSTRUMENT. ONE PHYSICIAN QUESTIONED THE LOW NA RESULT. MULTIPLE ERRONEOUS RESULTS WERE REPORTED OUT OF THE LAB. CUSTOMER PROVIDED ONLY ONE EXAMPLE OF A LOW PT RESULT AND THE REPEATED VALUE. WHILE THERE HAVE BEEN NO REPORTS OF SERIOUS PT CONSEQUENCES OR ADVERSE EVENTS, IT IS NOT KNOWN IF ANY PT TREATMENT WAS MODIFIED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK