BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS AU400 CLINICAL CHEMISTRY ANALYZER (AU481-03 ISE)

    MDR report key: 2300213 · Received October 19, 2011

    Report

    Report Number
    2050012-2011-06422
    Event Type
    Malfunction
    Date Received
    October 19, 2011
    Date of Event
    September 6, 2011
    Report Date
    September 19, 2011
    Manufacturer
    BECKMAN COULTER MISHIMAK.K.
    Product Code
    JJE
    PMA / PMN Number
    K981743
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WERE NOT PROVIDED. SAMPLE WAS SERUM. THE CUSTOMER PREVIOUSLY REPORTED THE SAME ISSUE IN MDR # 2050012-2011-04388 AND PATIENT SAMPLES WERE SENT TO CO. CLARE FOR TESTING. NO ABNORMALITIES WERE OBSERVED IN THE REACTION PROFILES OF THE SAMPLES WHICH WERE SENT. BECKMAN COULTER, INC. COMPLETED SYSTEM CHECKS AND HARDWARE UPGRADES FOR THE CUSTOMER AS OF (B)(4) 2011. THE INVESTIGATION FOR THIS ISSUE IS STILL ON GOING. THIS REPORT IS RELATED TO THE FOLLOWING MDRS THAT ARE BEING REPORTED ON DIFFERENT DATES FOR THE SIMILAR EVENTS THAT OCCURRED AT THIS CUSTOMER SITE: 2050012-2011-06418, 2050012-2011-06419, 2050012-2011-06420, 2050012-2011-06421, 2050012-2011-06423.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER, INC. (BEC) TO REPORT MULTIPLE INCORRECT CREATININE PATIENT SAMPLE RESULTS THAT WERE GENERATED ON THE AU481-03E WITH ISE CHEMISTRY ANALYZER, USED IN CONJUNCTION WITH CREATININE ENZYMATIC R1 AND R2 REAGENT (LOT 1625) OVER THE COURSE OF SIX (6) DAYS ((B)(6) 2011). THE SAMPLES EXHIBITED AN ABNORMAL REACTION PROFILE WITHOUT FLAGGING. THIS REPORT DOCUMENTS THE PATIENT RESULTS GENERATED ON (B)(6) 2011. THE SAMPLES WERE RERUN AND GAVE EXPECTED RESULTS WITH A NORMAL REACTION PROFILE. THE ORIGINAL CREATININE RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. THE CUSTOMER DID NOT REPORT AN EFFECT TO PATIENT AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS AU400 CLINICAL CHEMISTRY ANALYZER (AU481-03 ISE) ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER MISHIMAK.K. AU481-03 ISE NA

    Patients

    Seq Age Sex Outcome Treatment
    1