BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AU2700 CLINICAL CHEMISTRY ANALYZER

    MDR report key: 1755114 · Received July 13, 2010

    Report

    Report Number
    2050012-2010-00441
    Event Type
    Malfunction
    Date Received
    July 13, 2010
    Date of Event
    May 20, 2010
    Report Date
    July 13, 2010
    Manufacturer
    BECKMAN COULTER MISHIMA K.K.
    Product Code
    JJE
    PMA / PMN Number
    K003721
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QC WAS WITHIN ESTABLISHED RANGES PRE AND POST THE EVENT. CALIBRATION AND MAINTENANCE RECORDS WERE CURRENT. A BCI FIELD SERVICE ENGINEER (FSE) CHECKED THE ANALYZER. FSE VERIFIED FUNCTION AND ALIGNMENT OF THE UNIT. THE UNIT WAS IN PROPER WORKING CONDITION. A CLEAR ROOT CAUSE FOR THIS EVENT CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO FALSELY HIGH CHOLESTEROL (CHOL) RESULT GENERATED BY AU2700 CLINICAL CHEMISTRY ANALYZER. THE PHYSICIAN QUESTIONED THE RESULT. THE SAMPLE WAS REPEATED AND LOWER RESULT WAS OBTAINED. THE INITIAL AND RERUN SAMPLES ARE PROVIDED. THE FALSE RESULT WAS REPORTED OUT OF THE LABORATORY. PATIENT TREATMENT WAS NOT IMPACTED BY THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AU2700 CLINICAL CHEMISTRY ANALYZER AU2700 CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER MISHIMA K.K. N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1