Events

Retiro De Equipo (Recall) de Accu-Chek Spirit Combo insulin pump and Accu-Chek Spirit insulin pump. An in vitro diagnostic medical device (IVD)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Roche Diagnostics Australia Pty Limited.

¿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-00347-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2015-04-21
  • 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-00347-1
  • 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
    Roche has become aware that some customers are experiencing an increase of mechanical errors with their insulin pumps showing e6 & e10 error messages. this is associated with handling of the cartridge during the cartridge change process. roche has improved the handling instructions for the cartridge change to prevent the future occurrence of this issue.If users do not follow the cartridge change process step-by-step as described in the updated handling instructions, there is a potential risk of small insulin amounts to drip into the cartridge compartment, and result in a damage of the piston rod over time, so that the piston rod will not properly move and potentially limit or cause a blockage of the insulin pump motor function. eventually, this may result in the insulin not being delivered as intended. the issue is easily detectable as the pump will alert the user by acoustic, visual & vibration alerts.
  • Acción
    Roche is contacting all users and providing a training leaflet with step by step instructions to assemble the cartridge, adapter and infusion set tubing first, prior to inserting the new cartridge into the insulin pump. For more details, please see http://www.tga.gov.au/alert/accu-chek-spirit-combo-and-accu-chek-spirit-insulin-pumps . This action has been closed-out on 04/08/2016.

Device

Accu-Chek Spirit Combo insulin pump and Accu-Chek Spirit insulin pump. An in vitro diagnostic med...

Manufacturer

Roche Diagnostics Australia Pty Limited