BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM

    MDR report key: 23985251 · Received January 6, 2026

    Report

    Report Number
    1061932-2026-00001
    Event Type
    Malfunction
    Date Received
    January 6, 2026
    Date of Event
    December 12, 2025
    Report Date
    January 6, 2026
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    UDI-DI
    15099590687922
    PMA / PMN Number
    K140911
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE BECKMAN (BEC) CUSTOMER TECHNICAL SUPPORT (CTS) CONFIRMED THAT THE INSTRUMENT GENERATED ERRONEOUSLY HIGH PLT AND MPV PARAMETER RESULTS. ONSITE SERVICE WAS SCHEDULED. THE BEC FIELD SERVICE ENGINEER (FSE) FOUND THE RBC BATH WAS DRAINING CONTINUOUSLY. THE FSE CHECKED THE SWEEP FLOW CHECK VALVE AND RBC BATH DRAIN VALVE AND FOUND THE RBC BATH DRAIN VALVE WAS NOT CLOSING PROPERLY. THE FSE REPLACED THE RBC BATH DRAIN VALVE (PART A90972) AND PERFORMED COMPLETE BLOOD COUNT (CBC) MODULE PRIME. THE ISSUE WAS NO LONGER OBSERVED. VERIFICATION WAS PERFORMED SUCCESSFULLY. THE ASSIGNABLE CAUSE OF THE EVENT IS A FAULTY RBC BATH DRAIN VALVE. BEC INTERNAL IDENTIFIER - (B)(4).

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THEIR DXH 800 HEMATOLOGY INSTRUMENT, PART B63322, SERIAL NUMBER (B)(6), GENERATED CONTROL FAILURES FOR THE RED BLOOD CELL (RBC), PLATELET (PLT), PLATELETCRIT (PCT) AND PLATELET DISTRIBUTION WIDTH (PDW) PARAMETERS AND R FLAGGING FOR THE PLT, MEAN PLATELET VOLUME (MPV) AND DIFFERENTIAL PARAMETERS. ERRONEOUS HIGH PLT AND MPV RESULTS WERE GENERATED FOR PATIENT SAMPLES. THERE WAS NO REPORT OF AN ADVERSE EVENT. ERRONEOUS RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO REPORT OF DEATH, INJURY, DELAY OR CHANGE TO PATIENT TREATMENT OR DIAGNOSIS AND THERE WAS NO REPORT OF HARM TO PATIENT OR OPERATOR. PATIENT DATA WAS PROVIDED FOR REVIEW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46920 UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER, INC. REMFG TN DXH800 REMANUFACTRED WITH FLOOR STAND 15099590687922

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown