BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AU640 CLINICAL CHEMISTRY ANALYZER

    MDR report key: 3981944 · Received August 5, 2014

    Report

    Report Number
    9612296-2014-00115
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Date of Event
    July 11, 2014
    Report Date
    July 17, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K961274
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER (BEC) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE INSTRUMENT. THE FSE REPLACED THE POTASSIUM AND CHLORIDE ELECTRODES AND ALL ISE TUBING. IN ADDITION, THE FSE RESEATED THE ELECTRODE STACK IN THE FLOW CELL, VERIFIED O-RINGS WERE PLACED PROPERLY, REMOVED BUBBLES FROM STACK AND INCOMING REFERENCE SOLUTION, TIGHTENED STACK MOUNTING BRACKET, CHECKED THE GROUNDING OF THE ISE SYSTEM, AND CLEANED THE ISE SYSTEM. UPON FOLLOW UP, THE CUSTOMER DID NOT REPORT ANY FURTHER ISSUES; THE CUSTOMER STATED THE ISE SYSTEM WAS NO LONGER USED TO TEST PATIENT SAMPLES.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN AU640 CLINICAL CHEMISTRY ANALYZER GENERATED ERRONEOUS POTASSIUM (K) RESULTS FOR TWO PATIENT SAMPLES. THE SAMPLES WERE RETESTED ON THE SAME INSTRUMENT AND ON AN ALTERNATE AU680 CLINICAL CHEMISTRY ANALYZER IN THE SAME LABORATORY; RETEST RESULTS ON THE ALTERNATE INSTRUMENT ARE CONSIDERED CORRECT. THERE WERE NO ERRONEOUS RESULTS REPORTED OUT OF THE LABORATORY AND THERE WAS NO IMPACT TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT. THE CUSTOMER STATED ION SELECTIVE ELECTRODE (ISE) QUALITY CONTROL (QC) RESULTS WERE WITHIN FACILITY ESTABLISHED RANGES. THE CUSTOMER TROUBLESHOOTED THE INSTRUMENT BY REPLACING THE K ELECTRODE, WHICH RESULTED IN A DROP IN CALIBRATION SLOPES, INDICATIVE OF ELECTRODE ISSUES. THE CUSTOMER THEN DETACHED AND CLEANED THE SAMPLE D-POT AND FLOW CELL. AFTER REINSTALLING, THE ION SELECTIVE ELECTRODE (ISE) GENERATED THERMISTOR TEMPERATURE ERRORS. THE ISE WASTE DRAIN WAS CHECKED FOR BUILDUP AND NO ISSUES WERE FOUND, BUT THE CUSTOMER NOTED THE DRAIN WAS MAKING A STRANGE NOISE THAT WAS NOT TYPICAL. THE CUSTOMER TURNED OFF THE ISE SYSTEM AND REQUESTED SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457845 AU640 CLINICAL CHEMISTRY ANALYZER ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER AU640WI-U8 NA

    Patients

    Seq Age Sex Outcome Treatment
    1