BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DXU 840M IRIS AUTOMATED URINE MICROSCOPY ANALYZER

    MDR report key: 21984446 · Received May 8, 2025

    Report

    Report Number
    2122870-2025-00081
    Event Type
    Injury
    Date Received
    May 8, 2025
    Date of Event
    April 8, 2025
    Report Date
    May 8, 2025
    Manufacturer
    BECKMAN COULTER IRELAND INC.
    Product Code
    KQO
    UDI-DI
    15099590748654
    PMA / PMN Number
    K022774
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CTS AGENT ENLISTED THE ASSISTANCE OF AN APPLICATIONS SPECIALIST TO PROVIDE ADDITIONAL SUPPORT FOR THE CUSTOMER. THE APPLICATIONS SPECIALIST IDENTIFIED THAT THE INSTRUMENT WAS NOT PROPERLY SET FOR THE DESIRED RESULT BY THE CUSTOMER. THE CUSTOMER DID NOT INITIALLY UNDERSTAND HOW THE INSTRUMENT NEEDED TO BE SET TO GET THE EXPECTED RESULTS. THE APPLICATION SPECIALIST INSTRUCTED THE CUSTOMER THAT THE INSTRUMENT NEEDS TO BE SET TO 'NOT' ENABLE AUTO BACTERIA GRADING. LABELING: PER DXU 840M INSTRUCTION FOR USE (IFU) USER MANUAL (PART NUMBER: C49320AA): -SECTION 6-19; AUTO-CLASSIFICATION: ¿BACTERIA <3 MICRONS IN SIZE ARE TOO SMALL TO BE AUTOMATICALLY IDENTIFIED BY AUTO-PARTICLE RECOGNITION (APR) AND REQUIRE A TECHNICIAN TO IDENTIFY AND GRADE. APR WILL AUTO-CLASSIFY BACILLI >3 MICRONS IN SIZE AS ISOLATED IMAGES. THE OPERATOR IS RESPONSIBLE FOR VERIFYING THAT THE CLASSIFIED PARTICLES DISPLAYED MATCH THEIR APPROPRIATE AUTO-CLASSIFICATION. THE PRESENCE/ABSENCE OF CLINICALLY SIGNIFICANT BACTERIA CHANGES THE VERIFICATION PROCESS. NO INSTRUMENT MALFUNCTION WAS IDENTIFIED RELATED TO THIS EVENT. BEC INTERNAL IDNETIFIER - CASE-(B)(4).

    Description of Event or Problem · 0

    THE CUSTOMER HAD GENERATED ERRONEOUS POSITIVE BACTERIA AND YEAST RESULTS ON PATIENT SAMPLES. SEVEN (7) PATIENT SAMPLES WITH ERRONEOUS BACTERIA AND YEAST TEST-RESULTS WERE RELEASED OUT FROM THE CUSTOMER¿S SITE. ONE PATIENT¿S SAMPLE¿S TREATMENT WAS IMPACTED WHERE THE PATIENT WAS PROVIDED PRESCRIBED ANTIBIOTICS TREATMENT WHEN THE PATIENT DID NOT REQUIRE IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1022372 DXU 840M IRIS AUTOMATED URINE MICROSCOPY ANALYZER AUTOMATED URINALYSIS SYSTEM KQO BECKMAN COULTER IRELAND INC. INSTRUMENT DXU 840M IRIS 15099590748654

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other