BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AU640 WITH ISE CLINICAL CHEMISTRY ANALYZER

    MDR report key: 2061340 · Received April 18, 2011

    Report

    Report Number
    2050012-2011-01203
    Event Type
    Malfunction
    Date Received
    April 18, 2011
    Date of Event
    March 16, 2011
    Report Date
    March 18, 2011
    Manufacturer
    BECKMAN COULTER MISHIMA K.K.
    Product Code
    JJE
    PMA / PMN Number
    K961274
    Removal / Correction Number
    NA
    Product Problem
    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. ADDITIONAL OR DELAYED TREATMENT OR A SPECIALIST CONSULT WAS ORDERED FOR SIX (6) PATIENTS DUE TO THE ERRONEOUS RESULTS. THE CUSTOMER WAS UNABLE TO INDICATE WHICH OF THE PATIENT RESULTS APPLIED TO THE TREATED PATIENTS. THIS REPORTABLE EVENT DOCUMENTS THE MALFUNCTION PORTION OF THIS EVENT. REPORT NUMBERS 2050012-2011-01202, 2050012-2011-01204, 2050012-2011-01205, 2050012-2011-01206, 2050012-2011-01207, AND 2050012-2011-01208 HAVE BEEN SUBMITTED FOR THE AFFECT TO PATIENT TREATMENT OF THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1