BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BECKMAN COULTER AU680 CLINICAL CHEMISTRY ANALYZER

    MDR report key: 3251221 · Received July 29, 2013

    Report

    Report Number
    9612296-2013-00094
    Event Type
    Malfunction
    Date Received
    July 29, 2013
    Date of Event
    July 7, 2013
    Report Date
    July 7, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K961274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) ASSISTED THE CUSTOMER WITH TROUBLESHOOTING OVER THE PHONE. THE FSE INSTRUCTED THE CUSTOMER TO BLEACH THE ISE (ION SELECTIVE ELECTRODE) SYSTEM AND ELECTRODES WITH 10% BLEACH. THE CUSTOMER STATED THAT CALIBRATION AND QUALITY CONTROL (QC) PASSED AFTER PRIMING BUT LOW TO NEGATIVE ANION GAPS WERE STILL OBSERVED. THE FSE VISITED THE CUSTOMER'S SITE AND THE FSE REPLACED THE REFERENCE ELECTRODE AND THE ISE DATA PRINTED CIRCUIT (PC) BOARD TO RESOLVE THE ISSUE. FAILURE MODE OF THE EVENT IS ATTRIBUTED TO THE REFERENCE ELECTRODE AND ISE DATA PC BOARD.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT AFTER PERFORMING THE WEEKLY MAINTENANCE ON THE BECKMAN COULTER AU680 CLINICAL CHEMISTRY ANALYZER, THE CUSTOMER OBTAINED NEGATIVE ANION GAPS FOR MULTIPLE PATIENT RESULTS. THE CUSTOMER PROVIDED DATA FOR FIVE (5) PATIENT RESULTS WHICH DEMONSTRATED A CHANGE IN THE SODIUM (NA) AND CHLORIDE (CL) VALUES BETWEEN THE ORIGINAL AND REPEATED RESULTS. THE CUSTOMER STATED THAT NO ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY AND THERE WAS NO CHANGE OR AFFECT TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT. THE CUSTOMER REPEATED THE SAMPLES ON AN ALTERNATE ANALYZER AND OBTAINED ACCEPTABLE ANION GAP RESULTS. A BECKMAN COULTER CTS (CUSTOMER TECHNICAL SUPPORT) ASSISTED THE CUSTOMER WITH TROUBLESHOOTING OVER THE PHONE. THE CTS REQUESTED FOR THE CUSTOMER TO CHECK THE TUBING AND REAGENTS BUT THE CUSTOMER DID NOT FIND ANY ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352197 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