BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER AC*T SERIES ANALYZER

    MDR report key: 2895431 · Received January 3, 2013

    Report

    Report Number
    1061932-2012-02944
    Event Type
    Malfunction
    Date Received
    January 3, 2013
    Date of Event
    December 12, 2012
    Report Date
    December 12, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K964988
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO BECKMAN COULTER, INC. THAT THE COULTER ACT 8/10 SERIES HEMATOLOGY ANALYZER HAS BEEN LEAKING FLUID. CUSTOMER REPORTED THE VOLUME OF THE LEAK WAS ABOUT 1 ML. CUSTOMER REPORTED THE COULTER ACT SERIES 8/10 ANALYZER GENERATED PLUS SIGNS ON THE WBC (WHITE BLOOD CELL) CONTROLS AND PATIENTS RESULTS. CUSTOMER REPORTED THE CONTROLS WERE WITHIN RANGE. CUSTOMER REPORTED PATIENT RESULTS WERE NOT AFFECTED. THERE WAS NO REPORT OF ANY ADVERSE EVENT OR INJURY REQUIRING MEDICAL INTERVENTION OR PATIENT TREATMENT. BEC FIELD SERVICE ENGINEER (FSE) DID NOT OBSERVE ANY LEAKS IN THE INSTRUMENT. CUSTOMER REPORTED THE PROBE WIPE WAS LEAKING. CUSTOMER INDICATED THEY REPLACED THE PROBE WIPE AND THE LEAK WAS RESOLVED. THE FSE VERIFIED THAT THE INSTRUMENT WAS NOT LEAKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2452 COULTER AC*T SERIES ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1