The Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom posted a field safety notice (FSN) concerning FreeStyle Libre Flash Glucose Monitoring System, manufactured by Abbott Diabetes Care.
According to the FSN, one of the safety features of the FreeStyle Libre System is the software, which is designed to disable the sensor if it identifies a possible loss of sensor power. In rare cases this disabling feature may not function correctly, and there is the potential for power loss to occur which may not be properly identified by the system. In these instances, when a scan is completed the sensor may provide previously collected glucose values as if they are current results. If this occurs, the results produced from the scan and seen on the Reader screen may be erroneous. However, the built-in blood glucose meter system is unaffected by this issue.
The above issue can be easily identified as the user would see the same glucose result on the screen each time they scanned during a period of power loss. They may also notice a gap in results on the 8-hour graph on the Reader screen.
If any reading from a scan seems unexpected or does not seem to match the way users are feeling, users should use the meter and test strips to perform a blood glucose test to verify the results produced by a scan. If the problem continues, users should contact Abbott Diabetes Care Customer Service. Furthermore, the manufacturer has made a change to the software that has corrected this issue for all newly manufactured FreeStyle Libre Sensors.
For details, please refer to MHRA website :
http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/fieldsafetynotices/CON462307
According to the local supplier, the affected products were not distributed in Hong Kong.
If you are in possession of the affected product, please contact your supplier for necessary actions.
Posted on 14 October 2014