BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 SYNCHRON® SYSTEM

    MDR report key: 2099926 · Received May 23, 2011

    Report

    Report Number
    2050012-2011-01789
    Event Type
    Malfunction
    Date Received
    May 23, 2011
    Date of Event
    April 26, 2011
    Report Date
    April 27, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FIELD SERVICE WAS NOT DISPATCHED AS THE ISSUE WAS PRESUMED TO BE SAMPLE RELATED. ION-SELECTIVE ELECTRODE (ISE) PERFORMANCE TESTING WAS VERIFIED REMOTELY BY TECHNICAL SUPPORT AND THE RESULTS MET ESTABLISHED SPECIFICATIONS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ON (B)(6) 2011 A SUPPRESSED POTASSIUM (K) RESULT WAS GENERATED ON THE UNICEL DXC 800 SYNCHRON SYSTEM FOR ONE PATIENT SAMPLE. A SYSTEM OUT OF INSTRUMENT RANGE (OIR) HIGH FLAG WAS ASSOCIATED WITH THE RESULT. THE SAMPLE WAS DILUTED AND RETESTED ON THE SAME INSTRUMENT. THE DILUENTS AND DILUTION RATIO IS UNKNOWN. THIS RESULT WAS REPORTED OUT OF THE LABORATORY. THE REPORTED RESULT WAS QUESTION BY THE PHYSICIAN. THE SAMPLE WAS RETESTED MULTIPLE TIMES ON (B)(6) 2011 IN BOTH SERUM AND PLASMA FORM. THE PLASMA RESULT WAS AGAIN SUPPRESSED WITH AN OUT OF INSTRUMENT RANGE (OIR) HIGH FLAG. A RETESTED DILUTED PLASMA SAMPLE PRODUCED HIGH RESULTS. THE SERUM SAMPLE GENERATED VALID RESULTS. THE REPORT WAS AMENDED WITH THE SERUM SAMPLE RESULTS. QUALITY CONTROL RESULTS PRIOR TO, AND AFTER, THE EVENT WERE FOUND TO BE WITHIN LABORATORY ESTABLISHED ACCEPTABLE RANGES. THERE WAS NO DEATH, SERIOUS INJURY OR CHANGE TO PATIENT TREATMENT ASSOCIATED OR ATTRIBUTED TO THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR