BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXH 560 COULTER CELLULAR ANALYSIS SYSTEM

    MDR report key: 23251624 · Received October 8, 2025

    Report

    Report Number
    1061932-2025-00030
    Event Type
    Malfunction
    Date Received
    October 8, 2025
    Date of Event
    September 22, 2025
    Report Date
    October 8, 2025
    Manufacturer
    BECKMAN COULTER IRELAND INC
    Product Code
    GKZ
    PMA / PMN Number
    K181475
    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 FIELD SERVICE ENGINEER (FSE) VERIFIED THE EVENT VIA TELEPHONE AND IDENTIFIED QUALITY CONTROL (QC) RECOVERED WITHIN SPECIFICATION AND REAGENT SUPPLY CONFIRMED DURING THE EVENT. THE FSE IDENTIFIED THE SAMPLE PROBE WAS AT ¿END OF LIFE¿ AND NEEDED TO BE REPLACED. THE FSE INSTALLED A NEW SAMPLE PROBE RESOLVING THE REPORTED EVENT. THE INSTRUMENT WAS VERIFIED WITH DAILY CHECKS, REPEATABILITY, AND QC. ALL RECOVERED WITHIN SPECIFICATION AND WITHOUT ERROR. BEC INTERNAL IDENTIFIED - CASE (B)(4).

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT ONE PATIENT SAMPLE RECOVERED WITH HIGH RBC, HEMOGLOBIN (HGB), HEMATOCRIT (HCT) AND PLATELET (PLT) RESULTS WHEN CYCLED ON THE DXH560 AL HEMATOLOGY INSTRUMENT (PN: B40603/SERIAL# (B)(6)) COMPARED TO A RERUN ON AN ALTERNATE INSTRUMENT. THERE WAS NO REPORT OF ERRONEOUS RESULTS BEING RELEASED FROM THE LABORATORY. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY, DELAY OR CHANGE TO PATIENT TREATMENT OR DIAGNOSIS. PRINTOUTS OF THE EVENT NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2610480 UNICEL DXH 560 COULTER CELLULAR ANALYSIS SYSTEM COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER IRELAND INC DXH 560 AL HEMATOLOGY ANALYZER

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown