BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM

    MDR report key: 4610084 · Received March 17, 2015

    Report

    Report Number
    1061932-2015-00472
    Event Type
    Malfunction
    Date Received
    March 17, 2015
    Date of Event
    February 20, 2015
    Report Date
    February 20, 2015
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K140911
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) EVALUATED THE INSTRUMENT ON 02/20/2015. THE FSE INDICATED THAT THE HGB CHAMBER WAS CLOUDY AND FILMED OVER AND CAUSED REGULAR DAILY CHECK FAILURES ON THE INSTRUMENT. THE FSE REPLACED THE CHAMBER AND RAN DAILY CHECKS TO CONFIRM PASSING HGB NUMERIC VALUES. THE SYSTEM OPERATION WAS VERIFIED. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED RECEIVING NON-NUMERIC HEMOGLOBIN (HGB) RESULTS ON DAILY CHECKS ON A UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM, AND REQUESTED A SERVICE VISIT. ERRONEOUS PATIENT RESULTS WERE NOT GENERATED AND THERE WAS NO CHANGE OR AFFECT TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    179894 UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1