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MHRA issues warning about FreeStyle Blood Glucose Meter and FreeStyle Mini Blood Glucose Meter

The Medicines and Healthcare products Regulatory Agency (MHRA) advised people with diabetes about a fault in specific blood glucose meters that may potentially produce incorrect low blood glucose results.

The manufacturer, Abbott Diabetes Care, has recalled their FreeStyle Mini Blood Glucose Meter and FreeStyle Blood Glucose Meter because they may give incorrect low blood glucose results when they are used with FreeStyle Lite and FreeStyle blood glucose test strips.

People with these models are being asked to contact the manufacturer to receive a new meter at no charge. These affected models have not been sold in the UK since 2007 and are used by around 11,000 people in the UK, some of whom may still be using them at home.

While awaiting a new meter, people should 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.

The manufacturer has already issued an alert to healthcare professionals and their customers and the MHRA is following this action up to ensure that healthcare professionals and the public are aware of this problem.

John Wilkinson, the MHRA’s Director of Medical Devices, said:

“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.

“Anyone who has these meters should contact the manufacturer Abbott Diabetes Care on 0500 467 466 who will provide you with a new one.”

Simon O’Neill, Director of Health Intelligence at Diabetes UK, said: “Blood glucose testing is an important part of diabetes management.

“People using these meters should follow the company’s instructions to receive a new meter. If they have any questions about their blood glucose readings, they should consult with their diabetes care team.”