Events

Retiro De Equipo (Recall) de D-TRONplus or Accu-Chek D-TRONplus series

Según L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en France que fue producido por Roche Diagnostics.

¿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
  • Fecha
    2006-05-12
  • País del evento
    France
  • Fuente del evento
    ANSM
  • URL de la fuente del evento
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/retrait-de-lots-de-piles-pour-pompes-a-insuline-d-tronplus-et-accu-chek-d-tronplus-roche-diagnostics
  • Notas / Alertas
    French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), 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 France.
  • Notas adicionales en la data
  • Acción
    ROCHE Diagnostics has withdrawn batches 4017121, 4017242 and 6020002 of insulin pump batteries from the D-TRONplus or Accu-Chek D-TRONplus series from the market on May 10, 2006 following claims of sudden stops without alarm of these pumps .. The company has directly notified the recipients (distributors and associations) of the batches of incriminated batteries with the message attached (12/05/2006) (49 KB) validated by Afssaps. The distributors and associations concerned will inform patients who use these pumps that could have received batteries belonging to these batches (message in annex (12/05/2006) (33 KB)). The relevant European Competent Authorities are informed of this measurement by the manufacturer. Read auss. Alert of August 30, 2006

Device

D-TRONplus or Accu-Chek D-TRONplus series

Manufacturer

Roche Diagnostics