Faulty Diabetes Glucose Meters - MHRA Recall

Faulty Diabetes Glucose Meters - MHRA Recall

I pass this on as several people here have said they have diabetes:

Press release: Medical devices regulator asks people with diabetes to check if they have faulty blood glucose meters

Date: 11 April 2013

Time: 13:00

Subject: Medical devices regulator asks people with diabetes to check if they have faulty blood glucose meters

Contact: Press Office 020 3080 7651

or press.office@mhra.gsi.gov.uk

Out-of-hours 07770 446 189

The MHRA today asked people with diabetes to check if they have a specific type of blood glucose meter at home. A software fault causes two specific models to either turn off or give a false low reading in the event that the blood glucose level is extremely high.

The OneTouch Verio Pro (serial numbers that start with RA, RB, RC, RD or RE) and the OneTouch Verio IQ (serial numbers that start with TA or TB) manufactured by LifeScan are blood glucose meter models that are used by people with diabetes at home. The OneTouch Verio meters are used by approximately 22,000 active users.

The manufacturer is recalling both models because the faulty software causes the OneTouch Verio Pro to give falsely low readings and the OneTouch Verio IQ to turn off in the unlikely event a person has an extremely high blood glucose level of 56.8 mmol/L and above.

This software issue affects all OneTouch Verio meters, including the OneTouch Verio Pro+ models that are used only in healthcare settings. The manufacturer has issued an alert to healthcare professionals about this issue.

The software fault in the specific meters could mean diagnosis and treatment are delayed. The MHRA wants people with diabetes to check if they have these meters at home and if they do, to contact LifeScan who will provide a fully-working replacement meter free of charge. OneTouch Verio strips and other models of Lifescan meters are not affected by the fault or recall.

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

“Extremely high blood glucose levels in people are rare, but if they do occur the person will require immediate medical attention.

“Protecting public health is our priority. If you have a Lifescan OneTouch Verio blood glucose meter, please telephone LifeScan on 0800 279 9118 (UK) or 1800 535 676 (Ireland) for a replacement.”

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 contact the manufacturer for a replacement but if they are concerned about their blood glucose readings, they should consult with their diabetes care team.”

mhra.gov.uk/NewsCentre/Pres...

There are, not surprisingly, various versions of this story across print and internet media. Thought the MHRA, being the ultimate source, was the one to post.

Rod

Picture is of a make of meter that is affected.

1 Reply

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  • Thank you for this information Rod. My son does not use this meter (or rather I don't on his behalf), but all information like this is gratefully received. Janet.

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