BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM

    MDR report key: 4570935 · Received March 4, 2015

    Report

    Report Number
    1061932-2015-00343
    Event Type
    Malfunction
    Date Received
    March 4, 2015
    Date of Event
    February 3, 2015
    Report Date
    February 3, 2015
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K120771
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 HGB AND NUCLEATED RED BLOOD CELL (NRBC) DAILY CHECK BACKGROUND FAILURES. THE FSE REPLACED THE HGB CHAMBER AND NRBC SAMPLE LINE TO THE DISTRIBUTION VALVE, RESOLVING THE DAILY CHECK ISSUES. THE SYSTEM WAS VERIFIED AND VALIDATED. (B)(4).

    Additional Manufacturer Narrative · 1

    UPON REVISION OF THE FILED MDR THE DEVICE MANUFACTURE DATE WAS CHANGED FROM 11/01/2013 TO 11/01/2012.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM GENERATED INCOMPLETE COMPUTATIONS (REPLACEMENT) CODES FOR HEMOGLOBIN (HGB) DURING DAILY CHECKS. THERE WERE NO ERRONEOUS NUMERIC RESULTS GENERATED AND PATIENT TREATMENT WAS NOT IMPACTED IN CONNECTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    150166 UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1