Events

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

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-00592-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2014-05-28
  • 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-00592-1
  • 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 diagnostics has identified that a small number of people with diabetes using the accu-chek mobile device have experienced falsely elevated blood glucose readings when using the system as a result of not following the described and labelled handling instructions. such improper handling can include, for example, unclean hands contaminated with glucose-containing substances, pressing the finger too hard and too long on the test field or smearing the blood while performing a test. roche has decided to enhance its training and handling instructions for the accu-chek mobile system – increasing their visibility in the meter kit to ensure people with diabetes’ understanding of how to appropriately use the system. this will enable the users to obtain safe and reliable blood glucose (bg) readings at all times.Br /br /the tga has published a web statement regarding this issue. for more information, pleaser refer to: http://www.Tga.Gov.Au/safety/alerts-device-accu-chek-glucose-meter-140606.Htm.
  • Acción
    Consumers are advised to continue to use their Accu-Chek Mobile device safely and reliably by carefully following the instructions that are described in the User Manual and which can also be found in a new instructions leaflet available at www.accu-chek.com.au. Specifically: · Wash your hands with warm water and soap. Dry your hands thoroughly before obtaining a blood sample. · Form a proper blood drop and apply it to the centre of the test field. · Immediately apply the blood gently to the test field after you have created the blood drop. · Do not press against the test field on the tape. · Touch the test area gently and your finger should be removed from the test field when the beep tone sounds and/or “test in progress” is displayed.

Device

Accu-Chek Mobile Blood Glucose Meter

Manufacturer

Roche Diagnostics Australia Pty Limited