Events

Retiro De Equipo (Recall) de Accu-Chek Connect Diabetes Management App for iPhone (iOS) v1.2.0(.5) (used in conjunction with Roche Accu-Chek Avica Connect and Accu-Chek Guide Blood Glucose Meters).

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-2016-RN-01168-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2016-09-07
  • 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-2016-RN-01168-1
  • 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 diabetes care has identified a programming error in the accu-chek connect diabetes management app ios version 1.2.0(.5) which under certain conditions could potentially lead to an inaccurate bolus insulin advice being provided to the patients. as a result of this issue the app “lightbulb” icon is not displayed and the correction bolus advice is not available.. the blood glucose (bg) value which could not be used initially may unintentionally become available for bolus advice calculation at a later time. if the patients then request a bolus advice for a bg value older than 10 minutes without taking and transferring a new bg measurement, it could lead to an incorrect bolus insulin recommendation. depending on the actual metabolic situation a potentially incorrect bolus advice could lead to serious health consequences.
  • Acción
    Roche is advising Health Care Professionals to inform their patients by distributing a copy of the letter, to whom the Accu-Chek Connect diabetes management app has been distributed. Patients are being advised to discontinue using version 1.2.0.5 and update their app immediately to version 1.2.2.2. This action has been closed-out on 12/05/2017.

Device

Accu-Chek Connect Diabetes Management App for iPhone (iOS) v1.2.0(.5) (used in conjunction with R...

Manufacturer

Roche Diabetes Care Australia Pty Ltd