Events

Retiro De Equipo (Recall) de Animas 2020 and Animas IR 1200 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 Australasian Medical & Scientific 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-00363-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2015-05-18
  • 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-00363-1
  • 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
    Animas has identified a software limitation included in the animas 2020 and animas 1200 insulin pumps. the software included in the animas 2020 insulin pump only operates until midnight on dec. 31, 2015. after this date, the pump will no longer deliver insulin and will generate a call service alarm. this end of use date is not currently included in our product labelling. the calendar software included in the animas 1200 will not recognise and store any date in 2016 or beyond. after midnight on dec. 31, 2015, the pumps’ calendars will revert to a previous year. this calendar issue is not currently included in our product labelling. although these pump models will continue to deliver insulin, if patients are using a data management software program with their pump, they will notice inaccuracies in the reports because of the incorrect dates.
  • Acción
    AMSL is replacing 2020 and IR 1200 pumps which are still in use with a new model Aminas Vibe Insulin Pump. This action has been closed-out on 24/08/2016.

Device

Animas 2020 and Animas IR 1200 Insulin Pumps

Manufacturer

Australasian Medical & Scientific Ltd