Events

Retiro De Equipo (Recall) de Guardian Connect Mobile App

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-2018-RN-00882-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2018-07-04
  • 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-2018-RN-00882-1
  • 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 identified an issue in apple ios 11.3 & 11.4 that can sometimes prevent patients from receiving a 'lost communication' alert after their guardian connect app is closed by the iphone's operating system (ios) in certain situations. the operating system may close the guardian connect app without alerting patients that the app is no longer running or communicating with the guardian connect transmitter. if the app is closed, patients will not receive alerts that could be associated with hypoglycaemic or hyperglycaemic events. medtronic have received reports from patients regarding the app closing without warning, however, to date, no reports of injury as a result of this issue have been received.
  • Acción
    Medtronic is advising users to immediately update their Guardian Connect App to the latest release (v3.2.2) located on the App Store. Medtronic also reminds users that as described in the App User Guide, Medtronic cannot guarantee that iPhones will always allow for the Guardian Connect App to run in the background. If the iPhone automatically closes your Guardian Connect App, users may receive a ‘Lost Communication’ alert. To ensure users continue receiving sensor glucose data and alerts, Medtronic recommends periodically checking that the Guardian Connect App is still running, being especially mindful of this anomaly when running several applications at once or after using gaming and video Apps which use a lot of the iPhone’s power or memory resources.

Device

Guardian Connect Mobile App
  • Modelo / Serial
    Guardian Connect Mobile AppPart number: CSS7200 ARTG Number : 276924(Medtronic Australasia Pty Ltd - Information system software, application program, patient record)
  • 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