Events

Retiro De Equipo (Recall) de Medtronic MiniMed Insulin Reservoirs

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-2013-RN-00690-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2013-07-05
  • 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-2013-RN-00690-1
  • 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
    There is the potential that reservoirs from the affected batches may have an increased risk of leaking. a leak in the reservoir may result in delivery of less insulin than needed. in addition, if the user has a leaky reservoir and an insulin blockage occurs in the infusion set, the pump may not alarm to notify them.
  • Acción
    Medtronic Diabetes is requesting customers to not use reservoirs from the affected batch. If no alternative product is available, customers are requested to switch to their back-up insulin injection plan. Replacement of affected batches can be arranged by contacting the Medtronic 24 Hour Help Line. For more details, please see http://www.tga.gov.au/safety/alerts-device-medtronic-minimed-130716.htm .

Device

Medtronic MiniMed Insulin Reservoirs
  • Modelo / Serial
    Medtronic MiniMed Insulin ReservoirsModel Numbers: MMT-326A and MMT-332ABatch Numbers: H8442973, H8463297, H8467888, H8469703, H8473271, H8478398, H8492449, H8494645, H8496561, H8510440, H8512826, H8517079, H8539013 and H8627745ARTG Number: 169959
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • 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