BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONCENTRA MASTERPLAN VER. 3.1 SP1 AND SP2

    MDR report key: 1245804 · Received November 20, 2008

    Report

    Report Number
    MW5009071
    Event Type
    Injury
    Date Received
    November 20, 2008
    Date of Event
    August 21, 2008
    Report Date
    November 20, 2008
    Manufacturer
    NUCLETRON B.V.
    Product Code
    MUJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE NUCLETRON B.V. MANUFACTURER OF THE ONCENTRA MASTERPLAN VER. 3.1 RADIATION THERAPY PLANNING SYSTEM, SENT ON 12 OF OCTOBER A CUSTOMER INFORMATION BULLETIN IN WHICH ALERTS THAT THE SOFTWARE FOR DOSE CALCULATION TO PATIENTS HAS AN INCONSISTENT DOSE CALCULATION AFTER REMOVING OR ADDING A WEDGE. THIS VERSION OF THE SOFTWARE WAS INSTALLED IN OUR HOSPITAL IN 2008. THIS MEANS THAT MORE THAN ONE HUNDRED PATIENTS COULD HAVE BEEN PROBABLY AFFECTED FROM THIS CALCULATION ERROR OR TREATMENT DOSE WITH POSSIBLE CONSEQUENCES FOR OVER DOSAGE OR UNDER DOSAGE. WE STARTED TO CHECK THE LIST OF PATIENTS AND WE SHALL RECALCULATE ALL THE PLANS TO VERIFY THESE CONSEQUENCES. DUE TO THE EXTREMELY SERIOUS PROBLEM, BEING THE ONCENTRA MASTERPLAN FDA APPROVED OR IT SEEMS SO, I WANT TO ALERT FDA FOR THIS EVENT. WAITING FOR YOUR KIND REPLY. HEAD OF MEDICAL PHYSICS DEPT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONCENTRA MASTERPLAN VER. 3.1 SP1 AND SP2 TREATMENT PLANNING SYSTEM MUJ NUCLETRON B.V.

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| O| R| S