BEUDAMED
    FDA Adverse Event Other Summary report: N

    MICROSELECTRON-HDR (MODEL 105.999)

    MDR report key: 215575 · Received March 16, 1999

    Report

    Report Number
    1121753-1999-00003
    Event Type
    Other
    Date Received
    March 16, 1999
    Date of Event
    February 18, 1999
    Report Date
    March 16, 1999
    Manufacturer
    NUCLETRON BV
    Product Code
    JAQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER WAS UNABLE TO WRITE TREATMENT PLAN TO A FLOPPY DISK FOR TRANSFER OF PLAN TO THE MHDR. CUSTOMER MANUALLY PROGRAMMED "TCS" BY USING THE TAB FUNCTION AND ARROW KEYS IN COMBINATION. CUSTOMER INADVERTENTLY CHANGED STEP SIZE FROM 2.5 TO 10 MM. THE RESULT WAS AN UNDERDOSE IN THE REGION INTENDED FOR TREATMENT AND UNINTENDED DOSE TO AN AREA OUTSIDE THAT REGION. CUSTOMER REPORTED THE NUCLEAR REGULATORY COMMISSION DEFINED MISADMINISTRATION TO NUCLEAR REGULATORY COMMISSION AND INFORMED NUCLETRON OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROSELECTRON-HDR (MODEL 105.999) REMOTE CONTROLLED RADIONUCLIDE APPLICATOR SYSTEM JAQ NUCLETRON BV MHDR MODEL 105.999 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other