BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOSAIQ

    MDR report key: 18451070 · Received January 5, 2024

    Report

    Report Number
    3015232217-2024-00002
    Event Type
    Malfunction
    Date Received
    January 5, 2024
    Date of Event
    December 8, 2023
    Report Date
    July 17, 2024
    Manufacturer
    ELEKTA SOLUTIONS AB
    Product Code
    IYE
    UDI-DI
    00858164002367
    PMA / PMN Number
    K183034
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6 UPDATED. H11 UPDATED: THE INVESTIGATION WAS COMPLETED BY CONDUCTING AN EVALUATION OF THE PRODUCT AND THE AVAILABLE REPORTED INFORMATION. THE CUSTOMER REPORTED A DISCREPANCY BETWEEN THE TOTAL DOSE AND THE FRACTION. ELEKTA HAVE CONTACTED THE CUSTOMER SEVERAL TIMES FOR DATA REQUIRED TO COMPLETE THE INVESTIGATION OF THE REPORTED PROBLEM. ELEKTA HAVE BEEN NOTIFIED THAT THE CUSTOMER'S RADIATION DEPARTMENT WOULD BE CLOSING DOWN ON 30 JUNE 2024 AND ARE UNABLE TO PROVIDE THE ADDITIONAL INFORMATION. ELEKTA ARE UNABLE TO DETERMINE THE CAUSE OF THE ISSUE REPORTED WITHOUT ADDITIONAL INFORMATION. FROM THE AVAILABLE INFORMATION IT WAS ASCERTAINED THAT THE PATIENT RECEIVED THE EQUIVALENT OF 27 FRACTIONS AT 1.8 CGY PER FRACTION INSTEAD OF THE INTENDED 25 FRACTIONS TO THE TREATMENT SITE. THIS REPRESENTS AN 8% RADIATION OVERDOSE TO THE TREATED AREA. HOWEVER, THERE WERE DAYS DURING THE ORIGINAL SCHEDULED 25 FRACTIONS WHERE THE TREATMENT WAS ONLY PARTIALLY GIVEN, THEREFORE MITIGATING THE THERAPEUTIC EFFECT OF THE DOSE. NO INJURY TO THE PATIENT WAS REPORTED BY THE CUSTOMER SINCE THE INITIAL REPORT OF THE INCIDENT. ELEKTA PHYSICS HAVE ASSESSED THIS AS A NON-SERIOUS RADIATION OVERDOSE.

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER'S INVESTIGATION IS ON-GOING AND FURTHER INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS COMPLETED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A DISCREPANY BETWEEN THE TOTAL DOSE AND THE FRACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1434691 MOSAIQ ACCELERATOR, LINEAR, MEDICAL IYE ELEKTA SOLUTIONS AB 00858164002367

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown