BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEM

    MDR report key: 2221098 · Received August 23, 2011

    Report

    Report Number
    2050012-2011-04721
    Event Type
    Malfunction
    Date Received
    August 23, 2011
    Date of Event
    July 25, 2011
    Report Date
    July 25, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER STATED ONGOING NA AND CL ISSUES ON THIS ANALYZER FOR ONE YEAR. SHE SAID NA RESULTS DRIFTS LOW, AND CL DRIFTS HIGH. THE RESULTS WILL BE OK FOR A WHILE AFTER RECALIBRATION. THE CUSTOMER HAS NOT TRACKED THE REPEATED PATIENTS RESULTS, AND DID NOT HAVE ANY EXAMPLES OF REPEATED RESULTS. THE CUSTOMER STOPPED USING THIS ANALYZER FOR ELECTROLYTES UNTIL SERVICE WAS ON SITE. QC PRIOR TO THE EVENT EXHIBITED IMPRECISION. SERVICE REPLACED THE CARBON BRIDGE AND VERIFIED THE INSTRUMENT PERFORMANCE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER, INC. (BEC) CONCERNING ERRONEOUSLY LOW SODIUM (NA) AND ERRONEOUSLY HIGH CHLORIDE (CL) RESULTS GENERATED BY UNICEL DXC 600 PRO SYNCHRON CLINICAL SYSTEM. THE RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. THE RESULTS RETURNED TO EXPECTED VALUES AFTER THE SYSTEM WAS RECALIBRATED. THERE WAS NO EFFECT TO PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER, INC. DXC 600 PRO NA

    Patients

    Seq Age Sex Outcome Treatment
    1