BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AU480 WITH ISE CHEMISTRY SYSTEM

    MDR report key: 2120926 · Received June 13, 2011

    Report

    Report Number
    2050012-2011-02332
    Event Type
    Malfunction
    Date Received
    June 13, 2011
    Date of Event
    May 13, 2011
    Report Date
    May 13, 2011
    Manufacturer
    BECKMAN COULTER MISHIMA K.K.
    Product Code
    JJE
    PMA / PMN Number
    K981743
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLES WERE TAKEN FROM PATIENT PORTS. THE SAMPLE WAS COLLECTED IN BD SST TRANSPORT TUBES. REPEATS WERE PERFORMED ON SAME SPECIMENS AS ORIGINAL. CALIBRATION DATA WERE WITHIN RANGE, HOWEVER, SLOPES FRO NA DECREASED FROM 50.4 TO 41.8, WHICH SIGNIFIES ELECTRODE REQUIRES REPLACING. QC WAS WITHIN RANGE BEFORE AND AFTER EVENT, BUT CUSTOMER IS RUNNING WITH NA QC RANGES OF +/- 20%. QC BEFORE EVENT WAS RUNNING 2.5% HIGH FOR SODIUM. BUFFER SOLUTION WAS REPLACED ON (B)(6) 2011 REFERENCE SOLUTION WAS REPLACED ON (B)(6) 2011 CUSTOMER REPLACED NA ELECTRODE AND MID SOLUTION ON (B)(6) 2011. SERVICE WAS NOT GENERATED A DEFINITIVE ROOT CAUSE CAN NOT BE DETERMINED FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO ERRONEOUS HIGH SODIUM (NA) PATIENT RESULTS GENERATED BY THE AU481-02E CHEMISTRY ANALYZER (AU480 WITH ISE). THE RESULTS WERE REPORTED OUT OF THE LABORATORY AND QUESTIONED BY A NURSE. THE SAMPLES WERE REPEATED AND LOWER RESULTS WERE OBTAINED. AMENDED REPORTS WERE INITIATED FOR ALL ION-SELECTIVE ELECTRODE (ISE) REGARDLESS IF THERE WAS A CHANGE IN RESULTS. PATIENT TREATMENT WAS NOT IMPACTED BY THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AU480 WITH ISE CHEMISTRY SYSTEM CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER MISHIMA K.K. AU480-ISE N/A

    Patients

    Seq Age Sex Outcome Treatment
    1