Events

Retiro De Equipo (Recall) de Medtronic Paradigm Insulin Pump

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-00267-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2013-03-27
  • 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-00267-1
  • 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: loose drive support cap – if the loose drive support cap is pressed on, it could result in the unintended delivery of additional insulin.Issue 2: sensor graph timeout (only affects paradigm veo (mmt-554 and mmt-754)) – this issue could prevent the auto-resume of basaldelivery 2-hours after a low glucose suspend event, which can result in elevated blood glucose values.Issue 3: water damage– this issue may result in a pump alarm or cause the buttons to stop working.
  • Acción
    Issue 1: Medtronic is asking consumers to regularly examine the pump especially after a shock or drop on a hard surface. If the drive support cap is sticking out, customers are asked to not press on this portion of the pump and to discontinue the use of the pump. Customers will need to manage their diabetes as per the back-up plan provided to them by their healthcare professional. Also, contact Medtronic 24 hour Helpline on 1800 777 808 (option 1). Issue 2: Medtronic is providing work around instructions to prevent this issue from occurring. Issue 3: Medtronic is asking customers to follow the user guide to prevent this issue from occurring.

Device

Medtronic Paradigm Insulin Pump

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