MEDICAL DEVICE ALERT – FreeStyle Libre flash glucose sensor

A medical device alert has been issued by the Medicines & Healthcare products Regulatory Agency (MHRA) for FreeStyle Libre flash glucose sensor

MEDICAL DEVICE ALERT

Ref: MDA/2019/003

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

1. Identify any patients experiencing skin reactions – this can include blistering, erythema and itching
2. 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
3. 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:

• England and Wales: Yellow Card website or Yellow Card App available on iOS devices and Android devices
• Northern Ireland: Northern Ireland Adverse Incident Centre (NIAIC) online form
• Scotland: Yellow Card website, Yellow Card App available on iOS devices and Android devices, or Incident Reporting and Investigation Centre (IRIC) (email iric@nhs.net to request a webform account)

Further information can be found on the MHRA section on the GOV.UK website.

Produced by NPA Pharmacy Services team January 2019.