BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALKALINE PICRATE, COLORIMETRY, CREATININE

    MDR report key: 2208554 · Received August 12, 2011

    Report

    Report Number
    2050012-2011-04297
    Event Type
    Malfunction
    Date Received
    August 12, 2011
    Date of Event
    July 11, 2011
    Report Date
    July 12, 2011
    Manufacturer
    BECKMAN COULTER MISHIMA K.K.
    Product Code
    CGX
    PMA / PMN Number
    K981743
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    CHANGE FROM: PATIENT 7, TO: PATIENT 8.

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS SERUM. AU400 SYSTEM ALERTED OPERATOR OF REAGENT EMPTY, SWITCHED TO NEXT SET OF CREATININE BOTTLES AND NOTIFIED OPERATOR CALIBRATION EXPIRED. ALL CREATININE RESULTS RUN WITH THIS EXPIRED CALIBRATION FLAGGED WITH B. CONTROLS FOR CALIBRATED CREATININE ARE ACCEPTABLE. NO CONTROL RESULTS FOR REAGENT WITH EXPIRED CALIBRATION DAILY MAINTENANCE, CALIBRATION, QC WAS RUN AFTER THE PATIENTS WERE IDENTIFIED AND ON ANOTHER INSTRUMENT WITH DIFFERENT CREATININE REAGENT BOTTLES CALIBRATED AT 7:20 AM ON (B)(4) 2011. SUBSEQUENT RESULTS APPEARED ACCEPTABLE. NO SERVICE CALL WAS GENERATED. THIS IS NOT A SYSTEM MALFUNCTION EVENT ROOT CAUSE IS USER ERROR. CREATININE IFU STATES REAGENT MUST BE CALIBRATED ONCE DAILY AND CONTROLS RUN THAT ARE ACCEPTABLE. ASSOCIATED WITH MDRS: 2050012-2011-04290, 2050012-2011-04291, 2050012-2011-04292, 2050012-2011-04293, 2050012-2011-04294, 2050012-2011-04295, 2050012-2011-04296, 2050012-2011-04298, 2050012-2011-04299, 2050012-2011-04300.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC (BEC) IN REGARDS TO ERRONEOUS CREATININE RESULTS FOR 11 PATIENTS FLAGGED EXPIRED CALIBRATION USED AND H ABOVE REFERENCE RANGE WERE REPORTED GENERATED BY THE OLYMPUS AU400 CLINICAL CHEMISTRY ANALYZER. TEN OF THE ELEVEN PATIENTS HAD BUN WITHIN THE REFERENCE RANGE. THE RESULTS WERE REPORTED OUT OF THE LABORATORY AND QUESTIONED BY THE PHYSICIAN. PATIENTS' SAMPLES WERE REPEATED ON ANOTHER INSTRUMENT WITH VALID CALIBRATION AND RESULTS WITHIN NORMAL REFERENCE RANGE WERE OBTAINED FOR 9 OUT OF THE 11 PATIENTS. TWO SAMPLE REPORTED H, HOWEVER >30% LOWER. THE REMAINING 10 PATIENT RESULTS WILL BE ADDRESSED ON SEPARATE MDRS. PATIENT TREATMENT AS NOT IMPACTED AS THE RESULTS WERE REVISED WITHIN 5 HOURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALKALINE PICRATE, COLORIMETRY, CREATININE CREATININE TEST SYSTEM. CGX BECKMAN COULTER MISHIMA K.K. CREATININE 1418

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR