BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM

    MDR report key: 4632955 · Received March 25, 2015

    Report

    Report Number
    1061932-2015-00529
    Event Type
    Malfunction
    Date Received
    March 25, 2015
    Date of Event
    March 3, 2015
    Report Date
    March 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
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) EVALUATED THE INSTRUMENT ON 03/04/2015. THE FSE INDICATED THAT HE REPLACED THE HGB VALVE, HGB ASSOCIATED TUBING, AND HGB CUVETTE (CHAMBER), WHICH HAD A CLOUDY APPEARANCE. THE HGB BLANK SHIFT ERRORS ARE ATTRIBUTED TO THE CLOUDY HGB CHAMBER. THE INSTRUMENT WAS INSPECTED AFTER THE CHANGE OF PARTS AND PASSED STABILITY FOR THE HGB OUTPUT. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED INTERMITTENT HEMOGLOBIN (HGB) BLANK SHIFT ERROR MESSAGES ON A UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM. THE CUSTOMER REQUESTED A SERVICE VISIT. ERRONEOUS PATIENT RESULTS WERE NOT REPORTED OUT OF THE LABORATORY 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
    200513 UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1