Events

Alerta De Seguridad O Notificaciones De Seguridad para Animas® IR 1200, Animas® 2020, One Touch® Ping® Glucose management system, Animas® Vibe™

Según Medicines and Healthcare products Regulatory Agency, este evento ( alerta de seguridad o notificaciones de seguridad ) involucró a un dispositivo médico en United Kingdom que fue producido por manufacturer #17429.

¿Qué es esto?

Las notificaciones de seguridad de campo son comunicaciones sobre acciones que se pueden estar tomando en relación con un producto que se encuentra en el mercado, enviadas por los fabricantes de dispositivos médicos o sus representantes. Estas notificaciones son principalmente para trabajadores de la salud, pero también para usuarios. Pueden incluir alertas y retiro de equipos.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert / Field Safety Notice
  • ID del evento
    MDA/2012/059
  • Número del evento
    CON180652
  • Fecha
    2012-08-22
  • Fecha de publicación del evento
    2012-08-22
  • País del evento
    United Kingdom
  • Fuente del evento
    MHRA
  • URL de la fuente del evento
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON180652?tabName=allTabs
  • Notas / Alertas
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 the United Kingdom.
  • Notas adicionales en la data
  • Causa
    Risk of compromised insulin therapy due to failure of the buttons caused by keypad wear. the manufacturer has noted an increase in customer complaints regarding the durability of the insulin pump keypad. deterioration has led to the coating tearing and the edge of the keypad peeling away from the pump. there are also reports of the keys becoming unresponsive or sticking. animas has consequently redesigned the keypad to improve durability. the manufacturer has found that the average time to failure is 18 months. animas distributed a patient notification letter on the 16 july 2012 (see appendix). there is updated information on the animas website (external link).
  • Acción
    Check the list of serial numbers affected in the Animas UK document. Ensure that patients using the pump are aware of: the potential for buttons to fail. the need to examine the keypad regularly for signs of wear, such as peeling or tearing of the keypad edge from the pump. the need to have a back-up insulin delivery method available at all times. Patients and healthcare providers should refer to the updated Animas patient information in the appendix. Patients who identify problems with, or have concerns about, their pump’s keypad should contact their health care provider and Animas customer technical support. Report any problems with the pump to the MHRA. Diabetes departments. Pharmacists. Those involved in procurement, supply and use of this device.

Device

Animas® IR 1200, Animas® 2020, One Touch® Ping® Glucose management system, Animas® Vibe™
  • Modelo / Serial
  • Descripción del producto
    Animas ambulatory insulin infusion pumps. Animas® IR 1200 Animas® 2020 One Touch® Ping® Glucose management system Animas® Vibe™ Devices distributed before February 2012 and which do not contain the revised keypad are affected.
  • Manufacturer
    manufacturer #17429

Manufacturer

manufacturer #17429