BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DXA 5000

    MDR report key: 23807913 · Received December 15, 2025

    Report

    Report Number
    3006655511-2025-00008
    Event Type
    Injury
    Date Received
    December 15, 2025
    Date of Event
    November 19, 2025
    Report Date
    December 15, 2025
    Manufacturer
    BECKMAN COULTER BIOMEDICAL GMBH
    Product Code
    JJE
    UDI-DI
    15099590720599
    PMA / PMN Number
    K190298
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ACTIONS WERE TAKEN IMMEDIATELY TO ADDRESS THE INJURY. THE INJURED BECKMAN COULTER APPLICATIONS SPECIALIST WAS GIVEN ICE TO REDUCE SWELLING ON SITE. THE SPECIALIST WAS ADVISED TO SEEK TREATMENT AT THE NEAREST EMERGENCY ROOM. MEDICAL PROFESSIONALS PROVIDED CARE FOR THE INJURY. THE PROBABLE CAUSE OF THE ALLEGED DEFICIENCY WAS THE UNIT COVER SLIPPING DURING INSTALLATION. THE FIELD SERVICE ENGINEER (FSE) AND CO-WORKERS WERE INSTALLING THE UNIT COVER FOR THE DXA STORAGE UNIT (ECSD) WHEN IT SLIPPED. THE COVER MADE CONTACT WITH THE HEAD OF THE BECKMAN COULTER APPLICATIONS SPECIALIST. THE INCIDENT OCCURRED WHILE THE SPECIALIST WAS WALKING NEAR THE ONGOING INSTALLATION ACTIVITIES. THERE IS NO EVIDENCE OF A SYSTEM MALFUNCTION. SECTION A2, A3, A4, A5 AND A6: INFORMATION NOT PROVIDED. THE BECKMAN COULTER INTERNAL IDENTIFIER IS (B)(4).

    Description of Event or Problem · 0

    DURING THE INSTALLATION OF A DXA 5000 AUTOMATION LINE, A BECKMAN COULTER APPLICATIONS SPECIALIST REPORTED AN INJURY. WHILE WALKING AROUND THE DXA STORAGE UNIT, SPECIFICALLY THE ENVIRONMENTAL CONTROLLED STORAGE UNIT (ECSD), DURING INSTALLATION ACTIVITIES, A UNIT COVER SLIPPED. THE UNIT COVER, WHICH WAS BEING MOUNTED, HIT THE SPECIALIST ON THE TOP OF THE HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    720901 DXA 5000 ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER BIOMEDICAL GMBH ASSY INSTRUMENT ECSD 13K ? STOR 15099590720599

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other