BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AU680 CHEMISTRY ANALYZER WITH ISE

    MDR report key: 2914524 · Received January 14, 2013

    Report

    Report Number
    9612296-2013-00003
    Event Type
    Malfunction
    Date Received
    January 14, 2013
    Date of Event
    December 18, 2012
    Report Date
    December 20, 2012
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K961274
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER CUSTOMER OBTAINED ERRONEOUS K RESULTS, A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE. THE FSE INSPECTED THE INSTRUMENT AND FOUND DEFECTIVE ISE REFERENCE VALVE AND REPLACED IT. THE ISE SYSTEM WAS PRIMED AND FLUID FLOW THROUGH THE FLOW CELL WAS RESTORED TO NORMAL. THE ISE SYSTEM WAS CALIBRATED FOR BOTH SERUM AND URINE WITH NO ISSUES. CUSTOMER PERFORMED QC RUNS FOR BOTH SERUM AND URINE AND ALL RESULTS WERE WITHIN ACCEPTABLE RANGES. SYSTEM OPERATION WAS VERIFIED TO MEET THE SPECIFICATIONS. SYSTEM VALIDATION WAS DOCUMENTED IN CUSTOMER QC RECORD. TO DATE, NO FURTHER ISE ISSUES HAVE BEEN REPORTED FROM THIS CUSTOMER SITE. FAILED REFERENCE VALVE CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 1

    ON (B)(6) 2012, A CUSTOMER REPORTED TO BECKMAN COULTER INC., (BEC) HAVING ISE FATAL ERROR THAT WAS STOPPING THE ION SELECTIVE ELECTRODE (ISE) SYSTEM ON THEIR AU680 CHEMISTRY ANALYZER AND CUSTOMER WAS UNABLE TO RUN THE ISES. CUSTOMER WORKED WITH BEC CALL CENTER TO ADDRESS THIS ERROR. PER CALL CENTER DIRECTIONS, THE CUSTOMER PERFORMED ENHANCED CLEANING, CHANGED ROLLER PUMP TUBING, REPLACED ALL ISE SOLUTIONS AS PART OF TROUBLESHOOTING THE ISSUE. CUSTOMER NEXT REPORTED THE ISE CALIBRATION FAILURE. CUSTOMER WAS REQUESTED TO PRIME THE SYSTEM AND SERVICE WAS DISPATCHED. PER PHONE CONVERSATION WITH A FIELD SERVICE ENGINEER (FSE) ON (B)(6) 2012, A DETERMINATION WAS MADE THAT AFTER ALL THE TROUBLESHOOTING THERE IS SOMETHING OBSTRUCTING THE ISE FLOW CELL. THE FSE HAD THE CUSTOMER REPLACE THE ELECTRODES. FOLLOWING THIS, THE CUSTOMER NOTED BUBBLES IN THE ISE LINES; HOWEVER, PRIMING THE ISE SYSTEM CLEARED THE BUBBLES. ON (B)(6) 2012, ISE CALIBRATIONS PASSED. CUSTOMER TESTED PATIENT SAMPLES AND REPORTED THAT FLAGGED POTASSIUM (K) RESULTS WERE GENERATED BY THE ANALYZER. THE SAMPLES WERE RE-TESTED AND K RESULTS OBTAINED WERE IN DIFFERENT RANGES. PATIENT RESULTS ARE PROVIDED IN THIS REPORT. NO ERRONEOUS RESULTS WERE REPORTED OUTSIDE THE LABORATORY. NO EFFECT TO PATIENT TREATMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19910 AU680 CHEMISTRY ANALYZER WITH ISE ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER INC. AU681-10E NA

    Patients

    Seq Age Sex Outcome Treatment
    1