Events

Alerte Ou Avis De Sécurité sur FreeStyle Libre flash glucose sensor

Selon Medicines and Healthcare products Regulatory Agency, ce/cet/cette alerte ou avis de sécurité concerne un dispositif en/au/aux/à United Kingdom qui a été fabriqué par Abbott.

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert / Field Safety Notice
  • Date
    2019-01-29
  • Date de publication de l'événement
    2019-01-29
  • Pays de l'événement
    United Kingdom
  • Source de l'événement
    MHRA
  • URL de la source de l'événement
    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
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    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.
  • Cause
    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.
  • Action
    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
  • Modèle / numéro de série
  • Manufacturer
    Abbott

Manufacturer

Abbott
  • Adresse du fabricant
    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
  • Société-mère du fabricant (2017)
    Abbott Laboratories
  • Commentaire du fabricant
    “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