BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 SYNCHRON® SYSTEM

    MDR report key: 2923503 · Received January 22, 2013

    Report

    Report Number
    2050012-2013-00029
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Date of Event
    January 3, 2013
    Report Date
    January 3, 2013
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JGS
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED FALSE LOW NA (SODIUM) RESULTS FOR 5 PATIENT SAMPLES INVOLVING A UNICEL DXC 600 SYNCHRON SYSTEM AND THE RESULTS WERE REPORTED OUT OF THE LABORATORY. THE CUSTOMER NOTICED THE ISSUE WITH LOW NA RESULTS AND SAMPLES WERE REPEATED. SIX NA RESULTS WERE AMENDED AND REPORTED OUT OF THE LABORATORY BUT THE DIFFERENCE FOR ONE SAMPLE WAS WITHIN ASSAY PRECISION CLAIMS. THERE WAS NO INJURY OR CHANGE IN PATIENT TREATMENT IN CONNECTION WITH THIS EVENT. BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) EXAMINED THE FLOWCELL AND FOUND CRACKS AROUND THE NA ELECTRODE PORT. THE FSE REPLACED THE FLOWCELL AND INSTRUMENT WAS VERIFIED PER ESTABLISHED PROCEDURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29669 UNICEL® DXC 600 SYNCHRON® SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JGS BECKMAN COULTER INC. N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR