Events

Retiro De Equipo (Recall) de Dexcom G4 PLATINUM and Dexcom G5 Mobile receiver (Continuous Glucose Monitoring Device).

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-2016-RN-00224-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-03-04
  • 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-2016-RN-00224-1
  • 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
    Dexcom noticed an increase in complaints related to audible alarms and alerts associated with dexcom g4 platinum and dexcom g5 receivers.As such, all dexcom customers are being notified that that may not receive an intended audible alarm or alert. as a result, if they rely on hearing the alarm or alert, they may not detect a severe hypoglycaemic (low glucose) or hyperglycaemic (high glucose) event. this includes the fixed low alarm at 3.1 mmol/l, which alerts the user with vibration first, followed by beeps 5 minutes later if not confirmed. the vibration alert should continue to work; however, the audible beeps may not function. the vibration function for the alerts and alarm cannot be disabled by the user.
  • Acción
    Emergo is providing customers with instructions on how to test the audible alarms to ensure they are functioning properly. If the alarms and alerts are not functioning, users are advised to contact the local distributor, Australasian Medical and Scientific Ltd (AMSL), for a replacement device. Dexcom is working on implementation of an improved speaker for the receivers. For more information please see https://www.tga.gov.au/alert/dexcom-continuous-glucose-monitor-receivers . This action has been closed-out on 10/05/2017.

Device

Dexcom G4 PLATINUM and Dexcom G5 Mobile receiver (Continuous Glucose Monitoring Device).

Manufacturer

Emergo Asia Pacific Pty Ltd T/a Emergo Australia