Events

Retiro De Equipo (Recall) de Medtronic MiniMed 640G Insulin Pumps

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-00632-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2015-07-20
  • 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-00632-1
  • 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
    Issue 1 – users could inadvertently extend the blood glucose timestamp for a given blood glucose value by 12 minutes leading to a potentially incorrect bolus dose calculation. medtronic is currently not aware of any malfunctions, complaints, adverse effects, disease, illness, injuries or confirmed deaths related to this issue; andissue 2 – the ‘max bolus exceeded’ & ‘high/low’ blood glucose notification warning pop-ups for the bolus wizard software are not timing out which may lead to confusion. there are no reported harms due to the combination of potential user error and pop up screens not timing out.
  • Acción
    Medtronic has updated the user guide to rectify this issue. For more details, please see https://www.tga.gov.au/alert/minimed-640g-insulin-pump. This action has been closed-out on 15/08/2016.

Device

Medtronic MiniMed 640G Insulin Pumps

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