Events

Retiro De Equipo (Recall) de Medtronic Minimed 640G Infusion Pump used in clinical trials

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-00061-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-01-29
  • 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-00061-1
  • 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 has implemented an amendment to the pump user guide for medtronic minimed 640g insulin pumps. the change involves the bolus delivery accuracy listed in the pump user guide for very small bolus amounts (less than 0.1 u). delivery accuracy for bolus volumes < 0.1 unit is now updated to ±20%, from ±5%. the delivery accuracy for bolus volumes = 0.1 unit remains ±5%, as does the delivery accuracy for basal delivery.Medtronic considers that there is not likely to be any clinical risk associated with this change in delivery accuracy.
  • Acción
    An update to the published Instructions for Use (IFU) regarding the stated resolution of the device at a dose of <0.1 Unit is to be circulated to customers. This action has been closed-out on 08/08/2016.

Device

Medtronic Minimed 640G Infusion Pump used in clinical trials
  • Modelo / Serial
    Medtronic Minimed 640G Infusion Pump used in clinical trialsModel Numbers: MMT-1511 & MMT-1512
  • 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