Events

Retiro De Equipo (Recall) de G5 Mobile Receiver Manufactured between January 2016 and February 2017

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Emergo Asia Pacific Pty Ltd T/a Emergo Australia.

¿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-2018-RN-00275-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2018-04-06
  • 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-2018-RN-00275-1
  • 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
    G5 mobile receivers manufactured between january 2016 and february 2017 may not adequately complete the power on sequence under specific conditions. specifically, when the receiver is turned on, the green loading bar on the initialization screen becomes stuck with no further progress. the user cannot clear this screen and the receiver cannot be used to track blood glucose values. this is due to a software defect affecting devices produced in the above timeframe, which renders the receiver unusable after shutting it down in a particular sequence. this is a detectable issue for users if they check the screen after turning it on. no adverse health consequences are anticipated if you make sure you have access to an alternative means of monitoring your blood glucose.
  • Acción
    Emergo is advising users to contact Australian Medical Scientific (AMSL) to obtain a replacement receiver. Supplemental instructions will be provided to users as an interim measure to prevent this issue occurring until users receiver an updated receiver.

Device

G5 Mobile Receiver Manufactured between January 2016 and February 2017
  • Modelo / Serial
    G5 Mobile ReceiverManufactured between January 2016 and February 2017 ARTG Number:169241(Emergo Asia Pacific T/a Emergo Australia - Glucose monitoring system, in vivo)
  • Manufacturer
    Emergo Asia Pacific Pty Ltd T/a Emergo Australia

Manufacturer

Emergo Asia Pacific Pty Ltd T/a Emergo Australia