BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DXA

    MDR report key: 12691229 · Received October 25, 2021

    Report

    Report Number
    3006655511-2021-00003
    Event Type
    Injury
    Date Received
    October 25, 2021
    Date of Event
    October 7, 2021
    Report Date
    October 25, 2021
    Manufacturer
    BECKMAN COULTER BIOMEDICAL GMBH
    Product Code
    CDD
    UDI-DI
    15099590720261
    PMA / PMN Number
    K190298
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FSE RECEIVED PRESCRIPTION PAIN MEDICATION AND WAS ON SICK LEAVE UNTIL (B)(6) 2021. THE FSE HAS SINCE FULLY RECOVERED FROM THE INJURY AND IS BACK ON DUTY WITHOUT REPORTING ANY FURTHER COMPLICATIONS DUE TO THE INCIDENT. THE CUSTOMER IS OPERATIONAL AND NO FURTHER CONTACT IS REQUIRED. ASSESSMENT OF THE AVAILABLE INFORMATION REVEALED, THAT DURING THE REATTACHMENT OF THE SIDE PANEL OF THE OUTPUT MODULE, THE FSE DID NOT FOLLOW INSTRUCTIONS OF THE CURRENT DXA SERVICE MANUAL SECTION "5.3.7.3 MOUNTING THE SIDE COVERS" WHICH INSTRUCTS THE INSTALLATION OF THE SIDE PANELS TO BE PERFORMED BY TWO (2) PEOPLE. (B)(6). THE BECKMAN COULTER INTERNAL IDENTIFIER IS (B)(4).

    Description of Event or Problem · 0

    DURING REPAIR OF A PUSH CAP FEEDER ERROR THE BECKMAN COULTER FSE (FIELD SERVICE ENGINEER) SUSTAINED A SHOULDER INJURY WHILST REATTACHING THE SIDE PANEL OF THE DXA OUTPUT MODULE. THE FSE RECEIVED PRESCRIPTION PAIN MEDICATION AND WAS ON SICK LEAVE UNTIL (B)(6) 2021. NO HOSPITALIZATION WAS REQUIRED. THE FSE SINCE HAS RECOVERED FROM THE INJURY. NO ERRONEOUS PATIENT RESULTS WERE GENERATED DUE TO THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1588748 DXA RADIOASSAY, VITAMIN B12 CDD BECKMAN COULTER BIOMEDICAL GMBH DXA 5000 65269326 15099590720261

    Patients

    Seq Age Sex Outcome Treatment
    1 Other