Events

Retiro De Equipo (Recall) de One Touch Verio IQ 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 Johnson & Johnson Medical Pty Ltd.

¿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-00243-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2013-03-27
  • 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-00243-1
  • 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
    At extremely high blood glucose levels of 56.8 mmol/l and above, the onetouch verio iq meter will turn off instead of displaying the message "extreme high glucose above 33.3 mmol/l" as intended. on restart the meter will enter set up mode.
  • Acción
    Patients are advised to continue using their OneTouch Verio IQ meter until the replacement meter arrives. However, if the meter unexpectedly turns off and enters set-up mode after turning it back on, the patient should contact their Diabetes Nurse Educator or Health Professional as this may be an indication of extremely high blood glucose. Distributors and health services are being advised to immediately return all affected product.

Device

One Touch Verio IQ Blood Glucose Monitoring System

Manufacturer

Johnson & Johnson Medical Pty Ltd