Events

Retiro De Equipo (Recall) de FreeStyle InsuLinx Blood Glucose Meter (An in vitro diagnostic medical device (IVD))

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-2013-RN-00321-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2013-04-12
  • 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-2013-RN-00321-1
  • 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 have determined that at extremely high blood glucose levels (56.8 mmol/l and above), the device will display and store in memory an inaccurate low result that is 56.8 mmol/l below the genuine result. for example, for a blood glucose result of 59.1 mmol/l, the meter will display and store a result of 2.3 mmol/l (59.1 mmol/l - 56.8 mmol/l = 2.3 mmol/l). if this occurs there may be a delay in identification and treatment of high blood glucose levels, or incorrect treatment may be recommended by the insulin calculator, if this feature is enabled on the meter.
  • Acción
    Abbot Diabetes Care has developed a software correction for the problem and is asking users with access to the internet to update the software of the device. For more details, http://www.tga.gov.au/safety/alerts-device-freestyle-insulinx-130417.htm .

Device

FreeStyle InsuLinx Blood Glucose Meter (An in vitro diagnostic medical device (IVD))

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