BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BECKMAN COULTER AU680 CLINICAL CHEMISTRY ANALYZER

    MDR report key: 3013215 · Received March 20, 2013

    Report

    Report Number
    9612296-2013-00036
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Date of Event
    February 25, 2013
    Report Date
    February 25, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K961274
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BECKMAN COULTER THAT THE BECKMAN COULTER AU680 CLINICAL CHEMISTRY ANALYZER GENERATED ERRONEOUSLY ELEVATED ION-SELECTIVE ELECTRODE (ISE) RESULT. THE RESULT WAS REPORTED OUT OF THE LABORATORY, BUT THE CUSTOMER STATED THAT THERE WAS NO CHANGE TO PATIENT TREATMENT. THE CUSTOMER DID NOT PROVIDE THE PATIENT RESULT. THE CUSTOMER STATED THAT QUALITY CONTROL PERFORMED BEFORE AND AFTER THE EVENT PRODUCED ELEVATED RESULTS. THE CUSTOMER STOPPED USING THE ANALYZER PRIOR TO CALLING FOR SERVICE. BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) VISITED THE CUSTOMER'S SITE AND CONFIRMED THAT THE ANALYZER GENERATED ELEVATED RESULTS BUT REPEAT TESTING PRODUCED RESULTS WITHIN THE RANGES. THE FSE NOTED CORROSION DAMAGE TO THE BUFFER VALVES' CONNECTION WHICH COULD HAVE VERY WELL CAUSED THE INTERMITTENT ERRONEOUS RESULTS, AND REPLACED THE BUFFER VALVES. THE FSE VERIFIED SYSTEM PERFORMANCE BY RUNNING CALIBRATIONS AND QUALITY CONTROL, AND OBTAINED RESULTS WITHIN SPECIFICATIONS. THE FSE HAD ALSO STATED THAT UPON FOLLOW-UP, THE CUSTOMER DID NOT REPORT OR DOCUMENT ANY FURTHER ISSUES AND THE SYSTEM IS OPERATIONAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115421 BECKMAN COULTER AU680 CLINICAL CHEMISTRY ANALYZER ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER AU681-02E NA

    Patients

    Seq Age Sex Outcome Treatment
    1