BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM

    MDR report key: 4565451 · Received March 3, 2015

    Report

    Report Number
    1061932-2015-00345
    Event Type
    Malfunction
    Date Received
    March 3, 2015
    Date of Event
    February 3, 2015
    Report Date
    February 3, 2015
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K140911
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER (BEC) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE INSTRUMENT. THE FSE OBSERVED BUILD UP IN THE HEMOGLOBIN (HGB) CHAMBER. THE FSE REPLACED THE HGB CHAMBER RESOLVING THE DAILY CHECK FAILURES. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED HEMOGLOBIN (HGB) DAILY CHECK FAILURES ON A UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM. THE CUSTOMER TROUBLESHOOTED THE INSTRUMENT WITH BECKMAN COULTER (BEC) CUSTOMER TELEPHONE SUPPORT VIA TELEPHONE AND WAS UNABLE TO RESOLVE THE ISSUE. THERE WERE NO ERRONEOUS RESULTS GENERATED AND PATIENT TREATMENT WAS NOT IMPACTED IN CONNECTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    147413 UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1