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Warning issued by MHRA over software fault in blood glucose meter used by diabetes patients

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Clinicians are being warned about a software fault in a type of blood glucose meter used by around 40,000 patients in the UK.

The Medicines and Healthcare products Regulatory Agency said the fault could give an incorrect low result in the rare event that the blood glucose level is extremely high.

Health professionals and patients are being asked to check if they are using the FreeStyle InsuLinx meter, which is manufactured by Abbott Diabetes Care.

The manufacturer issued an alert to healthcare professionals because the faulty software causes the meters to give a falsely low reading in the unlikely event a person has an extremely high blood glucose level of 56.8mmol/L and above.

John Wilkinson, the MHRA’s director of medical devices, said: “People are unlikely to have very high blood glucose levels but if they do, they need a fully working blood glucose meter so they can get immediate medical attention.

“Anyone who has the FreeStyle InsuLinx meter at home should contact the manufacturer on 0800 088 5521 who will either provide a new meter or provide advice about how to update the software on your current meter.”

Simon O’Neill, director of health intelligence at Diabetes UK, said: “People using these meters should follow the company’s instructions to update the software on their meter or contact the company directly for advice.

“If they are concerned about their blood glucose readings, they should consult with their diabetes care team.”

The new safety alert follows one issued on 11 April about software problems affecting two OneTouch Verio meters – both manufactured by LifeScan.

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