Events

Safety Alert Or Field Safety Notices for FreeStyle Libre flash glucose sensor

According to Medicines and Healthcare products Regulatory Agency, this safety alert or field safety notices involved a device in United Kingdom that was produced by Abbott.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Safety alert / Field Safety Notice
  • Date
    2019-01-29
  • Event Date Posted
    2019-01-29
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    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 / Alerts
    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.
  • Extra notes in the 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.
  • Reason
    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
  • Model / Serial
  • Manufacturer
    Abbott

Manufacturer

Abbott
  • Manufacturer Address
    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
  • Manufacturer Parent Company (2017)
    Abbott Laboratories
  • Manufacturer comment
    “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