BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM

    MDR report key: 4621725 · Received March 20, 2015

    Report

    Report Number
    1061932-2015-00507
    Event Type
    Malfunction
    Date Received
    March 20, 2015
    Date of Event
    February 25, 2015
    Report Date
    February 25, 2015
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K140911
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) EVALUATED THE INSTRUMENT ON 02/26/2015. THE FSE OBSERVED THE HGB CUVETTE DID NOT FILL PROPERLY WHEN PERFORMING BLANK READINGS AND NOTED A SMALL BLOCKAGE IN THE PORT OF SOLENOID VALVE VL167. THE VALVE, VL167 WAS REPLACED TO RESOLVE THE HGB BLANK SHIFT ISSUE. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED HEMOGLOBIN (HGB) BLANK SHIFT ERROR MESSAGES ON A UNICEL DXH 800 COULTER CELLULARANALYSIS SYSTEM, AND REQUESTED SERVICE. 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
    191212 UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1