Events

Retiro De Equipo (Recall) de Accu-Chek Spirit Combo 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 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-2014-RN-00576-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-05-30
  • 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-00576-1
  • 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
    There is an increased risk that the vibration alarm will not work, as a result of a changed component. this fault will only be detected at pump start up, when it will display an ‘e-7’ error message and give an audible signal, but will fail to start. safety features such as the continuing audio signal as well as a visual notification will enable the user to detect the issue immediately and thus prevent from using an incorrectly functioning device.Br /br /the tga has published a web statement regarding this issue. for more information, please refer the following link: http://www.Tga.Gov.Au/safety/alerts-device-accu-chek-insulin-pump-140606.Htm.
  • Acción
    Roche is advising Accu-Chek Spirit Combo users of the potential for frequent E7 errors and reinforcing the instructions on how to clear the error. If the E7 error occurs repeatedly users are requested to contact Roche for a replacement device. This action has been closed-out on 10/02/2016.

Device

Accu-Chek Spirit Combo insulin pump

Manufacturer

Roche Diagnostics Australia Pty Limited