Events

Retiro De Equipo (Recall) de Accu-Chek Connect diabetes management app

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-00007-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-01-05
  • 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-00007-1
  • 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 have identified two software issues with the accu-chek connect diabetes management app, v1.2.0, 1.2.2, 2.0.0 (ios & android). under certain conditions the affected versions may disregard historical bolus data potentially leading to an invalid bolus insulin recommendation being provided to the end user. additionally, it was discovered that pairing & using multiple meters with the ios version of the accu-chek connect app can, under rare circumstances cause the bolus advisor to fail to offer a blood glucose (bg) correction bolus recommendation within the eligible time window following a bg measurement (10 – 15 min). depending on a patient’s situation, a potentially incorrect bolus advice could lead to serious health consequences as e.G. a hypoglycaemia in case the impacted bolus advice function erroneously recommended a too high insulin dose. both issues may also cause the amount of active insulin displayed during the bolus calculation process to be incorrect.
  • Acción
    Roche have released an update to the app with both issues described above corrected. In addition, Roche will be placing an alert on their website www.accu-chek.com.au informing patients to ensure they use the latest app version available on the Apple App or Google Play store (1.2.3).

Device

Accu-Chek Connect diabetes management app

Manufacturer

Roche Diabetes Care Australia Pty Ltd