The Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom posted a medical device safety alert concerning FreeStyle InsuLinx Blood Glucose Monitoring System, manufactured by Abbott.
Abbott has determined that at extremely high blood glucose levels of 56.8 mmol/L and above, the FreeStyle InsuLinx meter will display and store in memory an incorrect test result that is 56.8 mmol/L below the measured result. For example, a blood glucose value of 59.1 mmol/L will be displayed and stored as a value of 2.3 mmol/L (59.1 mmol/L–56.8 mmol/L = 2.3 mmol/L).
If the FreeStyle InsuLinx meter displays an inaccurate low result, there may be a delay in identification and treatment of severe hyperglycemia, or incorrect treatment may be given.
Product recall and replacement is on-going from distributors and health care providers. The affected patients are advised to update the software on the affected meters immediately, or they can contact their local Abbott Diabetes Care Customer Service for assistance.
According to the local supplier, Abbott Diabetes Care, the affected product has not been distributed in Hong Kong.
For details, please visit the following MHRA website:
http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/fieldsafetynotices/CON261768
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 16 April 2013