MHRA medical device alert – FreeStyle Libre flash glucose sensor (Abbott) – Use of barrier methods to reduce skin reactions to the sensor adhesive

MHRA medical device alert – FreeStyle Libre flash glucose sensor (Abbott) – Use of barrier methods to reduce skin reactions to the sensor adhesive

January 29, 2019

MDA number: MDA/2019/003
Date issued 29th January 2019

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a medical device alert:

Problem

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.

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.

Deadlines for actions

Actions underway: 12 February 2019

Actions complete: 26 February 2019

Manufacturer contacts

Abbott Diabetes Care UK 
Customer Services Complaints (82) 
Freepost RRBS-BLAA-SEHT 
Maidenhead, 
SL6 4UD, 
United Kingdom 

Tel: 0800 170 1177

Opening Times: 08:00 – 22:00, Monday to Friday (excluding bank holidays)

ADChelpuk@abbott.com



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