MEDICAL DEVICE ALERT – FreeStyle Libre flash glucose sensor
30 Jan 2019
A medical device alert has been issued by the Medicines & Healthcare products Regulatory Agency (MHRA) for FreeStyle Libre flash glucose sensor
MEDICAL DEVICE ALERT
29 January 2019
FreeStyle Libre flash glucose sensor
(Manufactured by Abbott)
A medical device alert has been issued by the Medicines & Healthcare products Regulatory Agency (MHRA) for FreeStyle Libre flash glucose sensor.
Patients who have experienced an immune response (skin reactions) to the sensor adhesive are using creams, patches or sprays. However, as such barrier methods have not been tested by the manufacturer, there is a potential for such products to affect the performance of the device.
Action to take
- Identify any patients experiencing skin reactions – this can include blistering, erythema and itching
- Consider if it is suitable for these patients to continue using the FreeStyle Libre flash glucose sensor – community pharmacy teams can refer such patients to the patient’s diabetes clinic/GP
- Consider an alternative blood glucose monitoring system
All adverse reactions need to be reported to the local incident reporting system and/or national incident reporting authority, as appropriate:
Further information can be found on the MHRA section on the GOV.UK website.
Produced by NPA Pharmacy Services team January 2019.