BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOSAIQ

    MDR report key: 22607379 · Received July 25, 2025

    Report

    Report Number
    3015232217-2025-00047
    Event Type
    Injury
    Date Received
    July 25, 2025
    Date of Event
    June 10, 2025
    Report Date
    September 10, 2025
    Manufacturer
    ELEKTA SOLUTIONS AB
    Product Code
    IYE
    UDI-DI
    00858164002367
    PMA / PMN Number
    K183034
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H4: MANUFACTURING DATE IS NOT ON THE LABEL, BUT IT IS KNOWN SO FIELD H4 HAS BEEN COMPLETED WITH THIS INFORMATION. THE MANUFACTURER'S INVESTIGATION IS ON-GOING AND FURTHER INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS COMPLETED.

    Additional Manufacturer Narrative · 0

    H2 UPDATED, H6 UPDATED, H11 UPDATED. THE INVESTIGATION WAS COMPLETED BY CONDUCTING A THOROUGH EVALUATION OF THE PRODUCT AND THE REPORTED INFORMATION. THE CUSTOMER REPORTED THAT THE PATIENT WAS TREATED WITH AN INCORRECT ISOCENTER IN THE Y-DIRECTION. IN-HOUSE TESTING WAS PERFORMED USING THE PROVIDED TREATMENT PLAN, COMPUTERISED TOMOGRAPHY (CT) SCAN, AND STRUCTURE SET (SS) WHICH WERE IMPORTED INTO MOSAIQ. THE IMPORTED ISOCENTER VALUES MATCHED THE EXPECTED CO-ORDINATES IN THE REFERENCE STRUCTURE SET/ISOCENTER OF SITE SETUP. BASED ON THE TREATMENT EVENT DATA, IT APPEARS THAT SITE SETUP WAS CREATED MANUALLY BY A USER AND NO ISOCENTER VALUES WERE ENTERED. A PLAN FOR THE PATIENT WAS LATER IMPORTED BY ANOTHER USER. THE PRE-EXISTING SITE SETUP WAS EDITED WITH X:0, Y: 3, Z: -8 ISOCENTER VALUES. THE ENTRY OF Y: 3 INSTEAD OF Y: -3 FOR THE ISOCENTER IS DUE TO USE ERROR. THE PATIENT RECEIVED TREATMENT USING THE INCORRECT ISOCENTER (Y: 3) FOR ALL FIVE FRACTIONS. ELEKTA PHYSICS HAVE ASSESSED THIS AS A SERIOUS RADIATION OVERDOSE. MOSAIQ DID NOT HAVE ANY MALFUNCTION AND WAS WORKING AS DESIGNED AND INTENDED. THE FINDINGS OF OUR INVESTIGATION HAVE BEEN FORMALLY COMMUNICATED TO THE CUSTOMER VIA EMAIL.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE PATIENT WAS TREATED WITH AN INCORRECT ISOCENTER IN THE Y-DIRECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2381745 MOSAIQ ACCELERATOR, LINEAR, MEDICAL IYE ELEKTA SOLUTIONS AB VERSION 2.86.077 00858164002367

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other