BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXITRON

    MDR report key: 2354783 · Received November 15, 2011

    Report

    Report Number
    9611894-2011-00005
    Event Type
    Malfunction
    Date Received
    November 15, 2011
    Date of Event
    April 29, 2011
    Report Date
    November 15, 2011
    Manufacturer
    NUCLETRON B.V.
    Product Code
    JAQ
    PMA / PMN Number
    K070574
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FLEXITRON ISSUE WAS FOUND DURING COMMISSIONING AND IS NOT PART OF A CLINICAL WORKFLOW. (B)(4), NUCLETRON BV IS NOW SUBMITTING THIS MDR IN COMPLIANCE WITH THE CORRECTIVE ACTIONS OF THE FDA FORM 483.

    Description of Event or Problem · 1

    IF A PATIENT IS CREATED ON THE TCC OF FLEXITRON (BEFORE IMPORTING THE PLAN) WITH THE SAME ID AS IN THE (B)(6), IT IS POSSIBLE TO TYPE ANY NAME, D.O.B., SEX, ADDRESS ETC AND THE IMPORT WILL STILL WORK. ON THE PRINTOUT FROM THE TCC THE PATIENT DETAILS WILL BE THOSE ENTERED ONTO THE TCC AND NOT THOSE IMPORTED FROM THE TPS. THIS COULD CAUSE INCORRECT PATIENT CREDENTIALS TO BE LOGGED IN A TREATMENT REPORT IF THE APPROPRIATE QA CHECKS ARE NOT PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXITRON REMOTE CONTROLLED RADIONUCLIDE APP SYS. JAQ NUCLETRON B.V. 136149A01-00 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA TCC VERSION 1.2.1