BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNICEL DXH 900 COULTER CELLULAR ANALYSIS SYSTEM

    MDR report key: 24196290 · Received January 27, 2026

    Report

    Report Number
    1061932-2026-00003
    Event Type
    Injury
    Date Received
    January 27, 2026
    Date of Event
    December 30, 2025
    Report Date
    January 27, 2026
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    UDI-DI
    15099590701574
    PMA / PMN Number
    K140911
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE BECKMAN (BEC) CUSTOMER TECHNICAL SUPPORT (CTS) CONNECTED TO THE INSTRUMENT REMOTELY AND CONFIRMED NO ERRORS OR ISSUES WERE PRESENT AT THE TIME THE PATIENT SAMPLE WAS PROCESSED. THE CTS SUGGESTED RUNNING QUALITY CONTROL TESTS TO ENSURE THE UNIT WAS FUNCTIONING PROPERLY. THE CUSTOMER REPORTED THAT DURING THE COLLECTION OF THE SAMPLE, IT WAS SUSPECTED OF BEING CONTAMINATED AND THEY DID NOT SUSPECT INSTRUMENT MALFUNCTION. THERE WAS NO MALFUNCTION IDENTIFIED. BEC INTERNAL IDENTIFIER - (B)(4).

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THEIR DXH 900 HEMATOLOGY INSTRUMENT (PART C11478, SERIAL NUMBER (B)(6) GENERATED AN ERRONEOUS HEMOGLOBIN (HGB) RESULT OF 4.2 G/DL FROM A SUSPECTED CONTAMINATED SAMPLE INSTEAD OF THE CORRECT VALUE OF APPROXIMATELY 12 G/DL LEADING TO THE PATIENT RECEIVING AN UNNECESSARY BLOOD TRANSFUSION. ALL COMPLETE BLOOD COUNT (CBC) PARAMETERS WERE FOUND TO BE ERRONEOUS. IT WAS CONFIRMED THAT THE ADMIMISTRATION OF THE TRANSFUSION DID NOT HAVE AN ADVERSE IMPACT ON THE PATIENT. THE CUSTOMER REPORTED THAT DURING THE COLLECTION OF THE SAMPLE, IT WAS SUSPECTED OF BEING CONTAMINATED AND THEY DID NOT SUSPECT INSTRUMENT MALFUNCTION. PATIENT DATA WAS PROVIDED FOR REVIEW. ALL CBC PARAMETER RESULTS, [WHITE BLOOD CELL (WBC), RED BLOOD CELL (RBC), HEMATOCRIT (HCT), MEAN CORPUSCULAR VOLUME (MCV), MEAN CORPUSCULAR HEMOGLOBIN CONCENTRATION (MCHC), MEAN CORPUSCULAR HEMOGLOBIN (MCH), RED CELL DISTRIBUTION WIDTH (RDW), PLATELET (PLT) AND MEAN PLATELET VOLUME (MPV)], GENERATED FROM THE SUSPECTED CONTAMINATED SAMPLE WERE ERRONEOUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    257698 UNICEL DXH 900 COULTER CELLULAR ANALYSIS SYSTEM COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER, INC. TN DXH 900 HEMATOLOGY SYSTEM WITH FLOOR STAND 15099590701574

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other