BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM

    MDR report key: 2933954 · Received January 29, 2013

    Report

    Report Number
    1061932-2013-00121
    Event Type
    Malfunction
    Date Received
    January 29, 2013
    Date of Event
    December 20, 2012
    Report Date
    January 4, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K081930
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) PERFORMED COMPLETE BLOOD COUNT (CBC) FINE GAIN ADJUSTMENT AND FLOW RATE COMPENSATION PROCEDURES TO OPTIMIZE CBC APERTURE, AND ALSO PERFORMED SYSTEM OPERATION VERIFICATIONS PERTAINING TO CBC RECOVERY. THE CUSTOMER WAS ADVISED TO RECALIBRATE THE INSTRUMENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED ERRONEOUS HEMOGLOBIN AND HEMATOCRIT RESULTS, FOR ONE PATIENT, WITH CHECK FAILURES INVOLVING THE UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM, USED IN CONJUNCTION WITH S-CAL CALIBRATOR. THE RESULTS DID NOT CORRELATE ON TWO SAMPLE ANALYSES. REANALYZED RESULTS WERE CONSIDERED CORRECT AND RELEASED TO THE HOSPITAL. THE ERRONEOUS RESULTS WERE NOT RELEASED OUT OF THE LABORATORY. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT. BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38899 UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR