BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AU400 WITH ISE CHEMISTRY SYSTEM

    MDR report key: 1845685 · Received September 27, 2010

    Report

    Report Number
    2050012-2010-00844
    Event Type
    Malfunction
    Date Received
    September 27, 2010
    Date of Event
    August 22, 2010
    Report Date
    September 27, 2010
    Manufacturer
    BECKMAN COULTER MISHIMA K.K.
    Product Code
    JJE
    PMA / PMN Number
    K981743
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT'S RECORDS SHOW THAT QC AND CALIBRATION WERE FLUCTUATING BETWEEN (B)(6) 2010. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED: THE FSE REMOVED CUVETTE WHEEL AND FOUND COOLANT ON WHEEL AND TRENCH. THE FSE CLEANED CUVETTE WHEEL AND SONICATED ALL CUVETTES. A FEW DAYS LATER THE FSE REPLACED R SYRINGE AND R PROBE. QC AND PRECISION WERE ACCEPTABLE AFTERWARDS. IT WAS DETERMINED THAT COOLANT IN THE CUVETTE WHEEL AND R1/R2 REAGENT SYRINGE AND PROBE IS THE ROOT CAUSE FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING FALSE LOW CREATININE RESULTS GENERATED BY THE AU400 WITH ISE CLINICAL CHEMISTRY ANALYZER FOR MULTIPLE PATIENTS. THE PATIENT RESULTS WERE REPORTED OUT OF THE LAB. THE SPECIMENS WERE RE-TESTED AND AMENDED REPORTS WERE ISSUED. IT IS UNKNOWN IF PATIENT TREATMENT WAS AFFECTED IN CONNECTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AU400 WITH ISE CHEMISTRY SYSTEM AU400 WITH ISE CHEMISTRY ANALYSER JJE BECKMAN COULTER MISHIMA K.K. AU400-ISE

    Patients

    Seq Age Sex Outcome Treatment
    1