BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AU403-02E CLINICAL CHEMISTRY ANALYZER

    MDR report key: 2120892 · Received June 12, 2011

    Report

    Report Number
    2050012-2011-02306
    Event Type
    Malfunction
    Date Received
    June 12, 2011
    Date of Event
    May 12, 2011
    Report Date
    May 12, 2011
    Manufacturer
    BECKMAN COULTER MISHIMA K.K.
    Product Code
    JJE
    PMA / PMN Number
    K981473
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AU400 WITH ISE, CONTROLS AT TWO LEVELS WERE IN RANGE FOR ALL TESTS INCLUDING NA, K AND CL BEFORE AND AFTER THE EVENT. SERVICE REQUESTED TO PERFORM SCHEDULED PM AND CHECK ISE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC (BCI) TO REPORT ERRONEOUS LOW SODIUM (NA) RESULT ON ONE PATIENT GENERATED BY THE UNICEL DXC AU400 CLINICAL CHEMISTRY SYSTEM. THE RESULT WAS REPORTED VERBALLY TO ER BY THE LABORATORY AS 127 MEQ/L. ER QUESTIONED THE RESULT AND THE ION-SELECTIVE ELECTRODE (ISE) SAMPLE WAS REPEATED AND REPORTED AS 137 MEQ/L. NO REVISION TO LAB REPORT AS ONLY REPEAT VALUE REPORTED. PATIENT TREATMENT WAS NOT IMPACTED BY THIS EVENT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AU403-02E CLINICAL CHEMISTRY ANALYZER CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER MISHIMA K.K. AU 400 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR