Events

Retiro De Equipo (Recall) de CareLink Clinical Therapy Management Software (online diabetes management software)

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-2014-RN-01215-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-11-14
  • 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-2014-RN-01215-1
  • 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 a software error in the carelink clinical therapy management software that might result in an inaccurate display of temp basal time and duration in carelink clinical reports when uploading data from the minimed 640g (models mmt-1511 & mmt-1512) insulin pump. the overall insulin calculation and additional analysis are correct. this issue only affects the graph and the duration data point displayed on carelink reports. this issue does not occur with uploads from other medtronic insulin pump models.The carelink clinical therapy management software is only intended for use in clinical trials and should not be used to provide medical advice to patients or health care professionals.
  • Acción
    Medtronic is informing users to not to use the Temp Basal data for clinical consideration when reviewing CareLink Clinical reports. Medtronic’s next version of CareLink Clinical software will resolve this issue and is expected to be available early next year. This action has been closed-out on 11/08/2016.

Device

CareLink Clinical Therapy Management Software (online diabetes management software)
  • Modelo / Serial
    CareLink Clinical Therapy Management Software (online diabetes management software)Model Number: MMT-7334ARTG Number: 133091
  • 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