BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AU681-02E CLINICAL CHEMISTRY ANALYZER

    MDR report key: 3121203 · Received May 20, 2013

    Report

    Report Number
    9612296-2013-00066
    Event Type
    Malfunction
    Date Received
    May 20, 2013
    Date of Event
    April 17, 2013
    Report Date
    April 22, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    JGS
    PMA / PMN Number
    K961274
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED FOR THIS EVENT. THE FSE REPLACED THE ISE REFERENCE ELECTRODE, ISE BUFFER SYRINGE, AND SAMPLE PROBE. ISE WAS PRIMED, AND CALIBRATED SEVERAL TIMES. CALIBRATION WAS GOOD AND WITHIN SPECIFICATION. THIS WAS FOLLOWED BY PRECISION RUNS WHICH WERE WITHIN SPECIFICATION. ANION GAP RECOVERY WAS REVIEWED AND ACCEPTABLE. ALL QC RESULTS WITHIN FACILITY GENERATED RANGES. CUSTOMER WILL CONTINUE TO MONITOR FOR ABNORMAL RESULTS. ISE ISSUES CONTINUED SO THE FSE RETURNED ON-SITE. THE FSE PERFORMED BI-WEEKLY MAINTENANCE: CLEANED THE ISE D-POT AND FLOW CELL. ALIGNMENTS WERE CHECKED; NO ISSUES WERE NOTED. THE FSE STATED THAT THERE DID NOT SEEM TO BE ANY REFERENCE SOLUTION BEING USED AS THE VOLUME IN THE BOTTLE WAS STILL OVER HALF FULL AND HAD BEEN ON BOARD FOR ABOUT A MONTH AND A HALF. THE FSE REPLACED THE REFERENCE VALVE. THE ISE SYSTEM WAS PRIMED, CALIBRATED, AND PERFORMED QUALITY CONTROL (QC). THE FSE NOTED THAT THE PRECISION RUN WAS GOOD AND MEET ACCEPTABILITY. FSE ALSO RAN A SAMPLE COMPARISON BETWEEN INSTRUMENTS AND RECOVERED WITHIN ONE UNIT ON THE SAMPLE VALUES. NO FURTHER ISSUES WERE REPORTED. FAILURE MODE - FAILED REFERENCE VALVE. THE FOLLOWING MDRS ARE ASSOCIATED WITH THIS REPORT: 9612296-2013-00064, 9612296-2013-00065.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER (BEC) REPORTING THAT THE AU681-02E CLINICAL CHEMISTRY ANALYZER GENERATED ERRATIC IONIZED SELECTIVE ELECTRODE (ISE) RESULTS FOR SODIUM (NA), POTASSIUM (K), AND CHLORIDE (CL) ELECTROLYTES, IN ANY COMBINATION, ON THREE (3) DIFFERENT DAYS ((B)(6) 2013). THIS REPORT DOCUMENTS THE RESULTS OBTAINED ON (B)(6) 2013. THE CUSTOMER NOTED ISSUES WITH LOW ANION GAP RESULTS. CUSTOMER STATED THAT WHEN THE SAMPLES WITH LOW GAPS WERE REPEATED ON AN ALTERNATE AU ANALYZER, THE ISE VALUES WERE HIGHER AND ANION GAPS WERE NORMAL. CUSTOMER CONFIRMED THAT NO ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY. THE RESULTS PROVIDED BY THE CUSTOMER ARE SHOWN IN THIS REPORT. THERE HAS BEEN NO CHANGE TO PATIENT TREATMENT ATTRIBUTED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222080 AU681-02E CLINICAL CHEMISTRY ANALYZER ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JGS BECKMAN COULTER AU681-02E NA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR