Dexcom G6 Sensor: untested barrier methods to reduce skin reactions (DSI/2021/004)

Users of this continuous glucose monitoring system may experience adverse skin reactions to the sensor.

From:
Medicines and Healthcare products Regulatory Agency
Published
6 April 2021
Message type:
Device safety information
Issued:
6 April 2021

Dexcom has issued a Field Safety Notice on this identified problem. Use of barrier methods or patches is not recommended as this may affect the performance of the device.

Background: skin reactions to the Dexcom G6 sensor adhesive

The MHRA is aware that some users of the Dexcom G6 continuous glucose monitoring system have experienced adverse skin reactions under the sensor. Symptoms can include redness, swelling and blistering.
For certain users this is a skin hypersensitivity reaction rather than a simple irritation reaction. Hypersensitivity reactions, also known as allergic reactions, are an abnormal reaction involving the immune system to an otherwise harmless chemical.
This reaction may first appear sometime after the first time using the sensor. Once a person has become sensitised to the chemical in the adhesive, the skin will always react to it. Each time they apply the sensor, the reaction may become worse and appear more quickly.

Untested barrier methods have unknown effects on device performance

The MHRA is aware that some patients are using barrier creams or patches to reduce skin reactions. It is possible that this could affect the way the sensor works.

This problem may not be unique to the Dexcom G6 sensor adhesive. Patients who use a different brand of continuous glucose monitoring system should follow the actions below if they experience similar symptoms.

Actions for clinicians

  1. Identify patients who have skin reactions, which may include erythema, itching and blistering.

  2. Consider if continued use of this device for patients with skin reactions is suitable.

  3. Consider use of alternative glucose monitoring systems for these patients.

  4. Report skin reactions to the device manufacturer and through your healthcare institution’s local incident reporting system and/or your national incident reporting authority as appropriate: England, Scotland, Northern Ireland, Wales.

Actions for patients

  1. If you are having skin reactions to this sensor, contact your healthcare professional to discuss if you should continue to use this device.

  2. Report skin reactions to the device manufacturer and to MHRA through the Yellow Card scheme.

Updates to this page

Published 6 April 2021
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