Events

Retiro De Equipo (Recall) de Accu-Chek Connect diabetes management app – Bolus Advisor function

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 Diabetes Care Australia 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-2017-RN-00410-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-03-29
  • 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-2017-RN-00410-1
  • 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
    A software issue has been identified in the accu-chek connect diabetes management app versions 2.0.0, 2.0.1, and 2.1.0 (ios & android). under certain conditions, the affected app versions may cause the bolus advisor to reset and display an incorrect active insulin amount of 0.0 on the app’s home screen, which may lead to an incorrect bolus advice. no warning message is displayed to the user. depending on the individual patient’s metabolic situation, a potentially incorrect bolus advice could result in serious health consequences (e.G. hypoglycaemia). (please note that previous versions of the app are not affected by this software issue. no other roche product with a bolus advisor is affected. also, all other functions on the accu-chek connect app can still be used.).
  • Acción
    Roche Diabetes Care is requesting healthcare professionals to notify their patients to whom the Accu-Chek Connect diabetes management app bolus advisor has been prescribed, and advise them to discontinue using the bolus advisor function. Roche is advising users that an updated version is being developed and they will be informed once it is available. Consumers with the affected app versions are advised to liaise with their healthcare professional for further advice.

Device

Accu-Chek Connect diabetes management app – Bolus Advisor function
  • Modelo / Serial
    Accu-Chek Connect diabetes management app – Bolus Advisor function Versions 2.0.0, 2.0.1, 2.1.0 (iOS & Android)ARTG Number: 224385
  • Manufacturer
    Roche Diabetes Care Australia Pty Ltd

Manufacturer

Roche Diabetes Care Australia Pty Ltd