BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AU2700 CLINICAL CHEMISTRY ANALYZER

    MDR report key: 2749475 · Received September 18, 2012

    Report

    Report Number
    2050012-2012-01716
    Event Type
    Malfunction
    Date Received
    September 18, 2012
    Date of Event
    April 15, 2011
    Report Date
    July 2, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K003721
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER INITIALLY EXPERIENCED LOW FLIER IN (B)(6) OF 2011, AND A FIELD SERVICE ENGINEER (FSE) RESOLVED THE ISSUE BY REPLACING THE ION-SELECTIVE ELECTRODE (ISE) D-POT. THE EVENT RE-OCCURRED ONCE IN (B)(6) OF 2012. AT THOSE JUNCTURES SEVERAL HARDWARE PARTS WERE REPLACED, CLEANED, AND EXCHANGED. IN ADDITION, INSTRUMENT PART ALIGNMENTS WERE VERIFIED. CALIBRATIONS WERE VERIFIED AND CUSTOMER QC WAS ACCEPTABLE. A SERVICE REQUEST WAS INITIATED. A FIELD SERVICE ENGINEER (FSE) MONITORED THE SITUATION WITH THE CUSTOMER FOR THE NEXT TWO WEEKS. NO FLYERS WERE NOTED OR REPORTED, HOWEVER, THE CUSTOMER EXPRESSED CONCERNS ABOUT THE STATE OF THE D-POT. THE D-POT STATE WAS MONITORED FOR THE NEXT 6 DAYS WITH NO FLYERS BEING REPORTED. NO DOCUMENTATION WAS PROVIDED AT THE TIME OF EVENT. THE FAILURE MODE OF THE EVENT IS UNKNOWN. THE ISSUE WAS DISCOVERED DURING THE REVIEW OF SERVICE RECORDS. AT THE TIME OF THE SERVICE THE ISSUE WAS RESOLVED BUT THE FIELD PERSONNEL DID NOT INITIATE A RECORD OF THE INCIDENT IN THE DATABASE. BECKMAN COULTER HAS RE-MEDIATED THIS PROCESS AS PART OF THE QUALITY SYSTEM RE-MEDIATION EFFORT AND TRAINING HAS BEEN PROVIDED TO ENSURE THIS GAP IS RECOGNIZED AND ADDRESSED THROUGH A COMPLAINT RECORD. THIS EVENT IS ASSOCIATED WITH MDR REPORTS LISTED BELOW: 2050012-2012-01622 (SUBMITTED ON TIME), 2050012-2012-01714 (SUBMITTED LATE, PAST 30 DAYS), 2050012-2012-01715 (SUBMITTED LATE, PAST 30 DAYS), 2050012-2012-01726 (SUBMITTED LATE, PAST 30 DAYS).

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE CUSTOMER CONTACTED BECKMAN COULTER INC., (BEC) TO REPORT TWO HIGH ISE FLIERS THAT WERE GENERATED ON THE AU2700 CLINICAL CHEMISTRY ANALYZER ON (B)(6) 2011, AS WELL AS A DIRTY D-POT. THE LOW FLIERS WERE 10 MMOL/L BETWEEN TESTING AND WERE NOT CONCURRENT WITH THE AU ANALYZER IN THE LABORATORY. ACTUAL PATIENT DATA/VALUES WERE NOT PROVIDED. THE CUSTOMER REPEATED THE TEST ON THE SAME INSTRUMENT AND AN ALTERNATE ANALYZER. WHEN REPEATED ON AN ALTERNATE INSTRUMENT 7MMOL/L DIFFERENCE IN RESULTS WERE OBTAINED AND WHEN REPEATED ON THE SAME ANALYZER 9 MMOL/L DIFFERENCE WAS OBTAINED. ERRONEOUS RESULTS WERE NOT REPORTED OUT OF THE LABORATORY AND NO CHANGES TO PATIENT TREATMENT ARE ATTRIBUTED TO OR CONNECT TO THIS EVENT. CONTROLS WERE RUN BEFORE AND AFTER THE EVENT AND THE PERFORMANCE WERE ACCEPTABLE. THE UNIT IS CURRENTLY PERFORMING WITHIN QC SPECIFICATIONS WITH RESPECT TO CONTROLS (ACCURACY) AND REPRODUCIBILITY (PRECISION).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AU2700 CLINICAL CHEMISTRY ANALYZER ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER, INC. N/A

    Patients

    Seq Age Sex Outcome Treatment
    1