BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 600 SYNCHRON SYSTEM

    MDR report key: 2142185 · Received May 26, 2011

    Report

    Report Number
    2050012-2011-01646
    Event Type
    Malfunction
    Date Received
    May 26, 2011
    Date of Event
    August 31, 2009
    Report Date
    August 31, 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
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN FSE (FIELD SERVICE ENGINEER) WAS DISPATCHED TO THE SITE TO TROUBLESHOOT AND MAKE REPAIRS, HOWEVER, NO CLEAR ROOT CAUSE WAS DETERMINED. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS CONDUCTED BETWEEN 01/01/2008 AND 10/23/2010 FOR ADDITIONAL REPORTABLE EVENTS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BCI) ON (B)(4) 2009 THAT ERRONEOUSLY LOW SODIUM (NA) RESULTS WERE INTERMITTENTLY OBTAINED ON THEIR UNICEL DXC 600 INSTRUMENT. PRIOR TO EACH EVENT, THE ISE (ION-SELECTIVE ELECTRODE) SYSTEM WAS CALIBRATED AND NA QC (QUALITY CONTROL) RESULTS WERE WITHIN THE LAB'S ESTABLISHED RANGES. NO ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY. THERE WAS NO IMPACT ON PT TREATMENT SINCE NO ERRONEOUS RESULTS WERE ISSUED OUT OF THE LAB.

    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