Healthcare professionals and their patients are being warned about a fault in specific blood glucose meters that may potentially produce incorrect low blood glucose results.
The Medicines and Healthcare products Regulatory Agency said Abbott Diabetes Care has recalled its FreeStyle Mini Blood Glucose Meter and FreeStyle Blood Glucose Meter.
It follows revelations that the models may give incorrect low blood glucose results when they are used with FreeStyle Lite and FreeStyle blood glucose test strips.
The affected meters have not been sold in the UK since 2007, although around 11,000 people still use them to measure glucose levels.
These individuals are being asked to contact Abbott Diabetes Care in order to receive a new meter at no charge.
“People need to have a fully working blood glucose meter so they can monitor their blood glucose levels and if necessary bring their glucose levels back to a safe level,” said John Wilkinson, the MHRA’s director of medical devices.
“Anyone who has these meters should contact the manufacturer Abbott Diabetes Care on 0500 467 466 who will provide you with a new one.”
While waiting for a new meter, people are advised continue to monitor their blood glucose levels using their existing models but taking extra care to take notice of any signs of high blood glucose levels.
Abbott Diabetes Care has already issued an alert to healthcare professionals and their customers and the MHRA is doing its part by ensuring everyone gets the message.
“People using these meters should follow the company’s instructions to receive a new meter,” said Simon O’Neill, director of health intelligence at Diabetes UK.
“If they have any questions about their blood glucose readings, they should consult with their diabetes care team.”
- Read the MHRA device safety alert