Events

Retiro De Equipo (Recall) de Accu-Chek Mobile Blood Glucose Monitoring System

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-00438-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-04-17
  • 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-00438-1
  • 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 become aware of a limitation of accu-chek mobile glucose tests, which may lead to erroneously lowered blood glucose readings in patients undergoing ceftriaxone therapy. this antibiotic substance is used to treat a variety of infections such as respiratory infections or lower urinary tract infections and is only administered intravenously or intramuscularly. the interference is due to the effect of this antibiotic on the measuring system of the device. this limitation is not described in the product labelling.
  • Acción
    Roche Diabetes Care is advising users of this issue and update to the device's labelling. Patients with diabetes who are receiving therapy with ceftriaxone could be using the affected blood glucose monitoring (bGM) system. If this is the case then Roche is recommending customers to obtain an alternative bGM system for the duration of this therapy. For more details, please see http://www.tga.gov.au/safety/alerts-device-accu-chek-mobile-140422.htm .

Device

Accu-Chek Mobile Blood Glucose Monitoring System

Manufacturer

Roche Diagnostics Australia Pty Limited