Events

Retiro De Equipo (Recall) de Medtronic MiniMed Sure-T infusion sets

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Medtronic Australasia Pty Ltd.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    RC-2015-RN-00506-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-06-19
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00506-1
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Notas adicionales en la data
  • Causa
    Medtronic identified that certain minimed sure-t infusion sets had a slight increase of reported cases where the steel needle broke during use. in a small number of these reported cases, the needle break led to hospitalisation for the management of glucose levels and/or treatment for removal of the needle. since then, an improvement in the needle manufacturing was implemented, which has reduced the number of reported cases of needle breaks.
  • Acción
    In the event consumers wish to carry on with using the old needle they are reminded to follow the current IFU along with specific additional instructions in the customer letter; OR if they prefer users (including members of the public) can phone Medtronic for replacement with unaffected stock. For more details, please see https://www.tga.gov.au/alert/medtronic-minimed-sure-t-infusion-sets. This action has been closed-out on 12/08/2016.

Device

Medtronic MiniMed Sure-T infusion sets
  • Modelo / Serial
    Medtronic MiniMed Sure-T infusion setsModel Numbers: MMT-860, MMT-862, MMT-863, MMT-864, MMT-865, MMT-866, MMT-870, MMT-873, MMT-874, MMT-875, MMT-876, MMT-883, MMT-884, MMT-885, MMT-886ARTG # 119216
  • Manufacturer
    Medtronic Australasia Pty Ltd

Manufacturer

Medtronic Australasia Pty Ltd
  • Empresa matriz del fabricante (2017)
    Medtronic plc
  • Comentario del fabricante
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    DHTGA