BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AU681-02E CLINICAL CHEMISTRY ANALYZER

    MDR report key: 1843239 · Received September 24, 2010

    Report

    Report Number
    2050012-2010-00825
    Event Type
    Malfunction
    Date Received
    September 24, 2010
    Date of Event
    August 27, 2010
    Report Date
    September 23, 2010
    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
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER CHANGING THE LEVEL SENSOR, ZERO RESULTS WERE STILL BEING PRODUCED BY THE ANALYZER. THE SAMPLE ARM ASSEMBLY WAS REPLACED. A BCI FIELD SERVICE ENGINEER (FSE) HAS BEEN WORKING WITH THE ACCOUNT TO RESOLVE THE ISSUE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING A LEVEL SENSE DETECTION PROBLEM ON THE AU 681-02E CLINICAL CHEMISTRY ANALYZER. NO PATIENTS WERE IMPACTED. INCORRECT RESULTS WERE NOT REPORTED OUTSIDE THE LABORATORY. ZERO OR NEGATIVE RESULTS ARE REPEATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AU681-02E CLINICAL CHEMISTRY ANALYZER CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER MISHIMA K.K. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1