Events

Alerta De Seguridad O Notificaciones De Seguridad para FreeStyle Libre flash glucose sensor

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 Abbott.

¿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
  • Fecha
    2019-01-29
  • Fecha de publicación del evento
    2019-01-29
  • País del evento
    United Kingdom
  • Fuente del evento
    MHRA
  • URL de la fuente del evento
    https://www.gov.uk//drug-device-alerts/freestyle-libre-flash-glucose-sensor-use-of-barrier-methods-to-reduce-skin-reactions-to-the-sensor-adhesive-mda-2019-003
  • 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
    MHRA is aware that some users of the FreeStyle Libre flash glucose monitoring system are applying barrier creams, patches and sprays before attaching the sensor to reduce skin reactions. These barrier methods have not been tested by the manufacturer and may therefore affect the performance of the device.The severity of the skin reaction can vary from person to person and for certain users this is a skin hypersensitivity reaction rather than an irritation reaction. For this type of reaction, once the person has become sensitised to the adhesive, every time the sensor is reapplied a skin reaction will occur. With each reapplication, the symptoms might appear more quickly and may worsen.The manufacturer has confirmed that they have revised the formulation of the adhesive, which will be available to UK customers from April 2019.Please note this problem may not be unique to the Abbott FreeStyle Libre sensor adhesive.
    The same actions should be taken if patients experience similar symptoms with a different brand of continuous glucose monitoring system.
  • Causa
    Manufactured by abbott – some users who are experiencing an immune response to the adhesive are applying creams, patches or sprays under their sensor to reduce skin reactions, which may affect device performance.
  • Acción
    Identify patients who have reported or may be experiencing skin reactions, which may include erythema, itching and blistering. Consider if continued use of this device for patients with skin reactions is suitable. Consider use of alternative glucose monitoring systems for these patients.This is consistent with the guidance already provided in the manufacturer’s instructions for use, which state:Some individuals may be sensitive to the adhesive that keeps the Sensor attached to the skin. If you notice significant skin irritation around or under your Sensor, remove the Sensor and stop using the FreeStyle Libre system. Contact your health care professional before continuing to use the FreeStyle Libre system.Report adverse events involving these devices through your local incident reporting system and/or your national incident reporting authority as appropriate: England, Scotland, Northern Ireland, Wales. You should also report directly to manufacturers if your local or national systems do not.

Device

FreeStyle Libre flash glucose sensor
  • Modelo / Serial
  • Manufacturer
    Abbott

Manufacturer

Abbott
  • Dirección del fabricante
    Abbott Diabetes Care UK Customer Services Complaints (82) Freepost RRBS-BLAA-SEHT Maidenhead, SL6 4UD, United KingdomTel: 0800 170 1177Opening Times: 08:00 - 22:00, Monday to Friday (excluding bank holidays)ADChelpuk@abbott.com
  • 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