Events

Retiro De Equipo (Recall) de FreeStyle Papillon Mini 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 Abbott Australasia Pty Ltd T/A Abbott Diabetes Care.

¿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-00167-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2014-02-20
  • 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-00167-1
  • 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
    Abbott diabetes care has identified through internal testing and investigation that all non-applied voltage legacy meters have the potential to produce out of range control solution results and/or give blood glucose results which could affect clinical outcome or have significant medical risk when used in conjunction with any freestyle test strip lot within expiry.Br /br /this is an update to the recall initiated in november 2013 on certain lots of freestyle blood glucose test strips (rc-2013-rn-01228-1). the freestyle papillion mini blood glucose monitoring system has not been supplied in australia since 2009.Br /br /further inforamtion on this recall can be found at http://www.Tga.Gov.Au/safety/alerts-device-freestyle-strips-papillon-mini-140304.Htm.
  • Acción
    Abbott is providing consumers who are still the possession of of a FreeStyle Papillion Mini blood glucose meter with a replacement FreeStyle branded meter.

Device

FreeStyle Papillon Mini Blood Glucose Monitoring System

Manufacturer

Abbott Australasia Pty Ltd T/A Abbott Diabetes Care
  • Empresa matriz del fabricante (2017)
    Abbott Laboratories
  • Comentario del fabricante
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    DHTGA