Events

Alerta De Seguridad O Notificaciones De Seguridad para Riata and Riata ST – all silicone coated models

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 St Jude Medical.

¿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/2014/009
  • Número del evento
    CON392815
  • Fecha
    2014-03-13
  • Fecha de publicación del evento
    2014-03-13
  • 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/CON392815?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
    These blood glucose meters may give incorrect low blood glucose results when they are used with freestyle lite and freestyle blood glucose test strips. abbott diabetes care is therefore asking people to stop using these affected meters and to contact them to get a replacement. the manufacturer has sent field safety notices, dated 19 february 2014, to customers. to deal with this problem when using freestyle navigator continuous glucose monitoring system (1.0 and 1.5 generation) and the freestyle blood glucose meter built into the omnipod insulin management system, follow the advice in the manufacturer’s field safety notice.
  • Acción
    Advise users to contact Abbott Diabetes Care customer services on 0500 467 466. Pharmacists supplying FreeStyle Lite and FreeStyle blood glucose test strips: When dispensing test strips advise users to contact Abbott Diabetes Care customer services for a replacement meter. Healthcare professionals managing patients: Advise users to contact Abbott Diabetes Care customer services for a replacement meter. This Medical Device Alert replaces MDA/2013/082R. Pharmacists supplying FreeStyle Lite and FreeStyle blood glucose test strips to patients who use the affected devices.

Device

Riata and Riata ST – all silicone coated models
  • Modelo / Serial
  • Descripción del producto
    Implantable cardioverter defibrillator (ICD) leads. Riata and Riata ST – all silicone coated models.
  • Manufacturer
    St Jude Medical

Manufacturer

St Jude Medical
  • Empresa matriz del fabricante (2017)
    Abbott Laboratories
  • Comentario del fabricante
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    MHRA