BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM

    MDR report key: 4394619 · Received January 7, 2015

    Report

    Report Number
    1061932-2015-00018
    Event Type
    Malfunction
    Date Received
    January 7, 2015
    Date of Event
    December 13, 2014
    Report Date
    December 13, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K140911
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE INSTRUMENT. THE FSE CLEANED THE INSIDE OF THE HGB CHAMBER (HGB) TO RESOLVE THE REPORTED ISSUE. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM FAILED DAILY CHECK FOR HEMOGLOBIN (HGB) ON STARTUP. BECKMAN COULTER (BEC) CUSTOMER TECHNICAL SUPPORT (CTS) TROUBLESHOOTED THE INSTRUMENT WITH THE CUSTOMER, BUT COULD NOT RESOLVE THE ISSUE. BEC FIELD SERVICE WAS DISPATCHED TO THE SITE. THERE WERE NO ERRONEOUS PATIENT RESULTS GENERATED AND PATIENT TREATMENT WAS NOT IMPACTED IN CONNECTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12641 UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1