Events

Retiro De Equipo (Recall) de Roche ACCU-CHEK Spirit Combo Insulin Pump

Según New Zealand Medicines and Medical Devices Safety Authority, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en New Zealand que fue producido por Roche Diabetes Care AG.

¿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
    17476
  • Fecha de inicio del evento
    2014-10-10
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: Roche Diagnostics (NZ) Ltd, 15 Rakino Way, Mt Wellington, AUCKLAND 1644
  • Causa
    Roche diabetes care has become aware that in a limited number of cases, patients using the accu-chek spirit combo insulin pump may experience a loss of the date and time settings. this issue may occur if the pump capacitor fails to function properly due to a leakage. the capacitor provides the necessary voltage to save time and date settings during power interruption, typically during a battery change.
  • Acción
    Manufacturer to issue advice regarding use

Device

Roche ACCU-CHEK Spirit Combo Insulin Pump

Manufacturer

Roche Diabetes Care AG