BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHADIA 250

    MDR report key: 24654292 · Received March 20, 2026

    Report

    Report Number
    3004973408-2026-00001
    Event Type
    Injury
    Date Received
    March 20, 2026
    Date of Event
    March 2, 2026
    Report Date
    March 20, 2026
    Manufacturer
    PHADIA AB
    Product Code
    DHB
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A PHADIA 250 WAS SCHEDULED FOR CONNECTION TO A LAS TRACK SYSTEM. TO INSTALL A PHADIA 250 INSTRUMENT TO THIS TYPE OF LAS (LABORATORY AUTOMATIONS SYSTEM) TRACKS, THE HEIGHT OF THE INSTRUMENT NEEDS TO BE ADJUSTED SINCE IT IS TOO HIGH FOR CONNECTION TO THE TRACK. TO DO THIS, THE EXISTING FEET ON THE INSTRUMENT NEED TO BE REPLACED WITH PARTS FROM PHADIA 250 LAS HARDWARE UPDATE KIT, 12-4907-27. THE PROCEDURE FOR REPLACING THE FEET IS DESCRIBED IN THE ADDENDUM TO PHADIA 250 SERVICE MANUAL, LAS CONNECTION TO LAS. THE PHADIA 250 INSTRUMENT WAS SUPPORTED WITH A LIFT JACK IN ACCORDANCE WITH THE INSTRUCTION, HOWEVER, WHILE THE INSTRUMENT WAS SUPPORTED BY THE LIFT JACK, IT BECAME UNSTABLE, TIPPED OVER BACKWARDS AND FELL AGAINST THE TRACK POSITIONED BEHIND IT. THE FSE WHO WAS TIGHTENING A BRACKET ON THE SIDE OF THE INSTRUMENT WAS STRUCK ON THE WRIST BY THE BRACKET AS THE INSTRUMENT FELL, RESULTING IN A WRIST INJURY. THE FSE RECEIVED MEDICAL EVALUATION, INCLUDING AN X-RAY, WHICH CONFIRMED THAT NO FRACTURE OCCURRED; THE INJURY WAS LIMITED TO SOFT TISSUE STRAIN AND BRUISING. NO SURGICAL INTERVENTION OR HOSPITALIZATION WAS REQUIRED.

    Description of Event or Problem · 0

    A PHADIA 250 INSTRUMENT WAS SCHEDULED FOR CONNECTION TO A LAS TRACK SYSTEM AT A CUSTOMER SITE IN DENMARK. DURING INSTALLATION, THE INSTRUMENT BECAME UNSTABLE, TIPPED BACKWARD, AND FELL AGAINST THE LAS TRACK POSITIONED BEHIND IT. THE FIELD SERVICE ENGINEER (FSE) WHO WAS TIGHTENING A BRACKET ON THE SIDE OF THE INSTRUMENT WAS STRUCK ON THE WRIST BY THE BRACKET AS THE INSTRUMENT FELL, RESULTING IN A WRIST INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    709306 PHADIA 250 PHADIA 250 (PHADIA LABORATORY INSTRUMENT) DHB PHADIA AB 12-3900-01 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention