MHRA Issues Diabetes Recall Notice

MHRA Has Told Consumers To Return A Blood Glucose Monitor To The Manufacturer

14.03.2014

The Medicines and Healthcare Products Regulatory Agency (MHRA) has issued a recall notice for a blood glucose monitor.

Concerns have been raised about the FreeStyle Mini Blood Glucose Meter, as well as the FreeStyle Blood Glucose Meter, because they often give incorrect readings that could leave people with diabetes at risk.

Consumers have been told the problem will normally only occur when the two devices are used with FreeStyle Lite and Freestyle blood glucose test strips, which are often used at the same time.

People with these devices have been told by the MHRA to return their meter to the manufacturer so that they can receive an updated replacement at no charge.

While the affected machines have not been sold on the UK market since 2007, it is believed they are still used by 11,000 people across the country - leaving public health officials worrying about the impact the situation may have on people with acute diabetes.

Diabetics regularly monitor their blood glucose levels to make sure they are at healthy levels, as their body does not produce the necessary amount of insulin.

Until a replacement device arrives, diabetic people with the FreeStyle Blood Glucose Meter are being told to keep using it, as it is better than guessing.

But in the mean time, patients are being asked to keep an eye on any symptoms - including dizziness, fainting or numbness in limbs - which are signs of low or high blood sugar.

John Wilkinson, 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."

It is unclear when replacement models will be sent out to affected customers, or if the process has already begun.

Expert Opinion
We would urge anyone with diabetes who owns one of these monitors to heed the warnings of the MHRA and ensure that the devices are returned, particularly considering the significant risks they could face if they are indeed given an incorrect reading.

"It is very concerning to hear of these issues and it is vital that the manufacturer thoroughly investigates how this fault emerged, with the ultimate priority being to ensure that the issue does not arise in relation to future products.

"A huge number of people place their faith in products of this kind and it is vital that they are always function to the required and necessary standard."
Lisa Jordan, Partner