BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AU640 WITH ISE CLINICAL CHEMISTRY ANALYZER

    MDR report key: 2061338 · Received April 18, 2011

    Report

    Report Number
    2050012-2011-01206
    Event Type
    Injury
    Date Received
    April 18, 2011
    Date of Event
    March 16, 2011
    Report Date
    March 18, 2011
    Manufacturer
    BECKMAN COULTER MISHIMA K.K.
    Product Code
    JFY
    PMA / PMN Number
    K961274
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE CUSTOMER, NO QC WAS RUN AFTER THE CALIBRATION OF CREATININE REAGENTS WAS COMPLETED. SERVICE WAS NOT REQUESTED WITH REGARD TO THIS EVENT. THE LABORATORY MANAGER REQUESTED THAT AN APPLICATIONS SPECIALIST COLLECT INFORMATION FOR THE INVESTIGATION. APPLICATIONS SPECIALIST WENT TO THE LABORATORY AND COLLECTED CALIBRATION, CONTROL AND PATIENT RESULT DATA AT THE LABORATORY. THIS EVENT WAS CAUSED BY USER ERROR. NO CONTROLS WERE RUN AFTER INITIAL CALIBRATION OF THE NEW CARTRIDGE OF CREATININE REAGENT INSTALLED ON INSTRUMENT, WHICH IS THE ROOT CAUSE OF THIS EVENT. INSTRUCTIONS FOR USE REQUIRE CONTROLS RUN AFTER CALIBRATION. PER THE CUSTOMER, TEST NOT IN CONTROL AFTER CALIBRATION. ERROR TRACED TO ONE OF TWO CALIBRATION REPLICATES THAT FALSELY INCREASED CALIBRATION FACTOR BY 60%, CAUSING ERRONEOUS CREATININE RESULTS TO BE GENERATED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO OBTAINING ERRONEOUSLY HIGH CREATININE (CRE) RESULTS AND CALCULATED ELECTRONIC - GLOMERULAR FILTRATION RATE (EGFR) THAT WERE REPORTED OUT OF THE LABORATORY FOR ONE HUNDRED AND THIRTEEN (113) PATIENTS, GENERATED BY THE AU640 WITH ISE CLINICAL CHEMISTRY ANALYZER. THE RESULTS WERE REPEATED ON AN ALTERNATE INSTRUMENT. ONE PATIENT RECEIVED IV FLUIDS FOR HYDRATION DUE TO THE ERRONEOUS RESULTS. THE CUSTOMER WAS UNABLE TO INDICATE WHICH ONE OF THE PATIENT RESULTS APPLIED TO THE TREATED PATIENT. A SEPARATE MDR 2050012-2011-01203 WAS SUBMITTED FOR THE MALFUNCTION PORTION OF THIS EVENT. THIS REPORT IS RELATED TO THE FOLLOWING MDRS THAT ARE BEING REPORTED ON THE SIMILAR EVENTS THAT OCCURRED AT THIS CUSTOMER SITE: 2050012-2011-01202, 2050012-2011-01204, 2050012-2011-01205, 2050012-2011-01207, AND 2050012-2011-01208.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AU640 WITH ISE CLINICAL CHEMISTRY ANALYZER CLINICAL CHEMISTRY ANALYZER JFY BECKMAN COULTER MISHIMA K.K. AU640 W/ ISE NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other