The FreeStyle Libre flash glucose monitoring system reader kits, sensor kits and app were CE marked as class IIb devices in August 2014.
The company has stated that 2 Medicines and Healthcare products Regulatory Agency field safety notices have been issued in relation to FreeStyle Libre:
2014/010/002/081/016: A software feature designed to disable the sensor in the event of a possible loss of sensor power could malfunction, meaning that power loss could be missed. In these cases the sensor may provide previously collected glucose values as if they were current results. Advice was given to use the meter and test strips if this occurred and the company has since corrected this issue for all newly manufactured sensors.
2015/006/026/291/011: 22 individual sensors outside of the UK had a potential for erroneously high glucose results. Users were instructed to discontinue use and contact the company for replacements. The company implemented corrective actions.