BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOSAIQ

    MDR report key: 20976335 · Received December 19, 2024

    Report

    Report Number
    2950347-2024-00018
    Event Type
    Injury
    Date Received
    December 19, 2024
    Date of Event
    December 3, 2024
    Report Date
    February 7, 2025
    Manufacturer
    ELEKTA INC.
    Product Code
    IYE
    PMA / PMN Number
    K183034
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H11 UPDATED: THE CUSTOMER NEEDED TO CONFIRM IF THE CORRECT ISOCENTRE WAS TREATED. THE INVESTIGATION WAS COMPLETED BY CONDUCTING A THOROUGH EVALUATION OF THE PRODUCTS AND THE REPORTED INFORMATION. THE INVESTIGATION SHOWED THAT ON (B)(6) 2024, THE REFERENCE ISOCENTRE OF "BRAIN PTV01" WAS USED TO TREAT 3 FIELDS, THAT SHOULD HAVE USED "BRAIN PTV03". THIS RESULTED IN A PATIENT MISTREATMENT. IT WAS ALSO NOTED THAT THE ISOCENTRE FOR PTV01 WAS IMAGED AT 11:48 AND AGAIN AT 12:05 WITHOUT UTILIZING THE SYNERGISTIQ MODE, THIS IS THE RECOMMENDED MODE AS DOCUMENTED IN THE INSTRUCTIONS FOR USE: ELEKTA MEDICAL LINEAR ACCELERATOR INSTRUCTIONS FOR USE VOLUME 3 - XVI, SECTION 6.5.3.11. ELEKTA PHYSICS ASSESSED THE INCIDENT AND CONCLUDED THAT, IN THIS INCIDENT THE INCORRECT ISOCENTER WAS USED TO TREAT FIELDS ON A SINGLE DAY OF AN INTENDED 5 FRACTION TREATMENT. THE INTENDED DAILY DOSE WAS 600 CGY. THE ERROR IN ISOCENTER POSITION WAS ~1.7, 6.5, 3.8 IN THE X Y AND Z DIRECTIONS, RESPECTIVELY. GIVEN THE GEOMETRY THE TARGET WOULD HAVE BEEN MISSED (PTV03). THE ERROR IN DOSE IS 20%. THIS IS ASSESSED AS A SERIOUS RADIATION UNDERDOSE. AS THESE FIELDS WERE TREATED AT THE POSITION OF PTV01 THIS RESULTED IN AN OVERDOSE OF THAT PRESCRIPTION. THE INTENDED DOSE FOR PTV01 WAS 4 GY X 5 FRACTIONS, FOR A TOTAL OF 20GY. THE ADDITIONAL PHYSICAL DOSE ON THE DAY OF THE ERROR IS APPROXIMATELY 6GY, OR 30% OF THE INTENDED TOTAL DOSE AND 250% OF THE INTENDED DAILY DOSE. THIS IS ASSESSED AS A SERIOUS RADIATION OVERDOSE. THIS IS A RESULT OF USE ERROR. MOSAIQ DID NOT HAVE ANY MALFUNCTION AND WAS WORKING AS DESIGNED AND INTENDED.

    Additional Manufacturer Narrative · 0

    THE CUSTOMER NEEDED TO CONFIRM IF THE CORRECT ISOCENTRE WAS TREATED. THE INVESTIGATION WAS COMPLETED BY CONDUCTING A THOROUGH EVALUATION OF THE PRODUCTS AND THE REPORTED INFORMATION. THE INVESTIGATION SHOWED THAT ON (B)(6) 2024, THE REFERENCE ISOCENTRE OF "BRAIN PTV01" WAS USED TO TREAT 3 FIELDS, THAT SHOULD HAVE USED "BRAIN PTV03". THIS RESULTED IN A PATIENT MISTREATMENT. IT WAS ALSO NOTED THAT THE ISOCENTRE FOR PTV01 WAS IMAGED AT 11:48 AND AGAIN AT 12:05 WITHOUT UTILIZING THE SYNERGISTIQ MODE, THIS IS THE RECOMMENDED MODE AS DOCUMENTED IN THE INSTRUCTIONS FOR USE: ELEKTA MEDICAL LINEAR ACCELERATOR INSTRUCTIONS FOR USE VOLUME 3 - XVI, SECTION 6.5.3.11. (PLEASE SEE ATTACHED FILE FOR AN EXCERPT OF THIS IFU.) ELEKTA PHYSICS ASSESSED THE INCIDENT AND CONCLUDED THAT, IN THIS INCIDENT THE INCORRECT ISOCENTER WAS USED TO TREAT FIELDS ON A SINGLE DAY OF AN INTENDED 5 FRACTION TREATMENT. THE INTENDED DAILY DOSE WAS 600 CGY. THE ERROR IN ISOCENTER POSITION WAS ~1.7, 6.5, 3.8 IN THE X Y AND Z DIRECTIONS, RESPECTIVELY. GIVEN THE GEOMETRY THE TARGET WOULD HAVE BEEN MISSED (PTV03). THE ERROR IN DOSE IS 20%. THIS IS ASSESSED AS A SERIOUS RADIATION UNDERDOSE. AS THESE FIELDS WERE TREATED AT THE POSITION OF PTV01 THIS RESULTED IN AN OVERDOSE OF THAT PRESCRIPTION. THE INTENDED DOSE FOR PTV01 WAS 4 GY X 5 FRACTIONS, FOR A TOTAL OF 20GY. THE ADDITIONAL PHYSICAL DOSE ON THE DAY OF THE ERROR IS APPROXIMATELY 6GY, OR 30% OF THE INTENDED TOTAL DOSE AND 250% OF THE INTENDED DAILY DOSE. THIS IS ASSESSED AS A SERIOUS RADIATION OVERDOSE. THIS IS A RESULT OF USE ERROR. MOSAIQ DID NOT HAVE ANY MALFUNCTION AND WAS WORKING AS DESIGNED AND INTENDED. DUE TO AN ADMINISTRATIVE ERROR, THE ATTACHMENT WAS NOT ATTACHED TO THE PREVIOUS REPORT. IT IS NOW ATTACHED HERE.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    THE CUSTOMER NEEDED TO CONFIRM IF THE CORRECT ISOCENTRE WAS TREATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1950962 MOSAIQ ACCELERATOR, LINEAR, MEDICAL, PRODUCT CODE: IYE IYE ELEKTA INC. VERSION 2.83.053

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other