BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DXU 840M IRIS AUTOMATED URINE MICROSCOPY ANALYZER

    MDR report key: 22977423 · Received September 5, 2025

    Report

    Report Number
    2122870-2025-00095
    Event Type
    Injury
    Date Received
    September 5, 2025
    Date of Event
    August 9, 2025
    Report Date
    September 5, 2025
    Manufacturer
    BECKMAN COULTER IRELAND, INC.
    Product Code
    KQO
    UDI-DI
    15099590748654
    PMA / PMN Number
    K022774
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE BECKMAN FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE. THE FSE NOTED THAT THE RED CHECK VALVE IN THE FRONT LEFT OF THE INSTRUMENT WAS BROKEN; ONE OF THE TABS HOLDING THE TWO HALVES OF THE VALVE TOGETHER HAD BROKEN OFF. TO RESOLVE THE ISSUE, THE FSE REPLACED THE RED CHECK VALVE. THE OPERATOR WAS ASSESSED BY THEIR OCCUPATIONAL HEALTH DEPARTMENT THE OPERATOR HAD BRUISED BOTH KNEES, BRUISED AN ELBOW, AND REPORTED SHOULDER PAIN. THE OPERATOR WAS TAKING PAIN MEDICATION; HOWEVER, THE CUSTOMER DID NOT DIVULGE WHETHER THE PAIN MEDICATION WAS PRESCRIBED OR OVER THE COUNTER. ADDITIONALLY, THE OPERATOR WAS ICING THE AFFECTED AREAS AND RESTING. WITH THE INFORMATION AVAILABLE IT COULD NOT BE CONFIRMED WHETHER OR NOT MEDICAL INTERVENTION IN THE FORM OF PRESCRIBED MEDICATION WAS REQUIRED. THIS REPORT HAS BEEN SUBMITTED IN AN ABUNDANCE OF CAUTION. BECKMAN COULTER INTERNAL IDENTIFIER (B)(4).

    Description of Event or Problem · 0

    THE CUSTOMER¿S DXU 840M IRIS INSTRUMENT HAD AN UNCONTAINED LEAK RESULTING IN AN OPERATOR SLIPPING AND FALLING TO THE FLOOR. THE OPERATOR WAS WEARING THE PROPER PERSONAL PROTECTIVE EQUIPMENT (PPE) HOWEVER THEY CAME INTO CONTACT WITH THE LEAK UPON FALLING. THE LEAK CONSISTED OF LAMINA. THERE WAS NO DIRECT CONTACT TO MUCOUS MEMBRANES OR OPEN WOUNDS. THE OPERATOR WHO HAD SLIPPEDL ON THE LIQUID ON THE FLOOR WAS EXPECTED TO REPORT TO THEIR SITE'S OCCUPATIONAL HEALTH. NO ERRONEOUS PATIENT RESULTS WERE RELEASED OUT FROM THE CUSTOMER¿S LABORATORY IN RELATION TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1975656 DXU 840M IRIS AUTOMATED URINE MICROSCOPY ANALYZER DXU 840M IRIS KQO BECKMAN COULTER IRELAND, INC. INSTRUMENT DXU 840M IRIS 15099590748654

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other