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Inaccurate test strips lead to warning for diabetics

Author: Neil Fearn  Bullet  Dated: 22/08/2013

A health regulator has advised diabetics to avoid using strips which gauge blood glucose as the strips might incorrectly measure blood sugar levels.

Diabetes - Medical Negligence claims In light of the warning from the Medicines and Healthcare Products Regulatory Agency (MHRA), over 1.7million strips have been recalled.

The inaccuracies were revealed in November 2012 by the manufacturer Menarini, which halted UK distribution of the relevant batches. However, they did not pull the products from pharmacies.

Investigation

Why the company did not warn the MHRA until July about possible issues with the strips is now being investigated by the regulator, which is concerned about the product's availability at chemists or in home medicine cupboards.

An overdose of insulin can cause hypoglycaemia (hypo) due to abnormally low blood sugar levels. Symptoms of hypo include hunger, trembling or 'the shakes' and excessive perspiration.

Some people can experience slurred speech or loss of concentration, with failure to rebalance hypo with sugary food leading potentially to coma or even death.

3 million UK patients

In the UK, around 3m people have diabetes - almost 90% of these have Type 2 diabetes. Diabetics should frequently monitor their glucose with blood test strips and hand-held monitors.

The strip's readout advises whether an insulin injection is needed to lower excessive blood sugar, or if patients should boost their blood sugar levels by eating more.

The strips in question, which are distributed in packs of 50, might have been bought by some 34,000 people. However, there have been no reports of users being harmed.

Warning to diabetics

The MHRA has warned that diabetics should find out if they still possess any GlucoMen LX and GlucoMen LX PLUS blood glucose tests purchased between October and November 2012. If so, they should avoid using the strips.

The batches at fault are 3212219249 (expiry date 31/08/2014) and 3212214249 (expiry date 31/08/2014).

MHRA director of medical devices, John Wilkinson, said: "The fault has been resolved and the 2 affected lots of faulty test strips have not been sold in the UK since November. There is no evidence that any patients in the UK have been adversely affected by the faulty test strips."

Mr Wilkinson added that GPs, diabetes clinics and other healthcare professionals will be able to advise patients what alternative test strips they can use.

Follow MHRA advice

According to experts, incorrect readings could risk the health of thousands of diabetics who rely on glucose test strips.

"We would urge people with diabetes who use testing strips to follow advice from the Medicines and Healthcare products Regulatory Agency and check their test strips to see if they are from these batches," said Bridget Turner of Diabetes UK. "If they are, they should not use them and take them back to their pharmacist or their GP."

Strong cases for medical negligence claims

Anyone with diabetes who becomes ill through use of the faulty strips will have a strong case for a medical negligence claim.

It's crucial that patients who might be affected take heed of the MHRA's advice. If you are uncertain of your position, it's worth taking specialist legal advice.

The manufacturer of the GlucoMen LX strips, Menarini, could not be contacted for comment.

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