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It is recognized that a manufacturer may wish to submit a small number  of "prototype models" of a device to clinical investigation in order to assess safety and/or performance; and those such prototypes may need to undergo a number of changes prior to large-scale production.

Regulator asks people to check their diabetes meters

The Medicines and Healthcare products Regulatory Agency (MHRA) is asking people with diabetes who use Accu-Chek® Mobile blood glucose meters to ensure they follow the important testing instructions. This is because the meter may give false high blood glucose readings if testing instructions are not followed accordingly.

The manufacturer, Roche Diabetes Care, has identified a small number of people using the strip-free Accu-Chek Mobile blood glucose monitoring system who have experienced falsely high blood glucose readings. This meter requires users to follow different testing instructions compared to other diabetes meters. If this procedure is not followed correctly an incorrect reading may be given even though the meter is working properly.

The manufacturer has issued enhanced training and handling instructions which are available online.

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

“People using this particular blood glucose monitoring device are enouraged to access the updated testing instructions at:
www.accu-chek.co.uk/mobilepropertesting (external link)

“An incorrect blood glucose reading can lead to people using the incorrect dose of insulin which, in some circumstances, could lead to an extremely low blood sugar (hypoglycaemia) and this may have serious consequences.

“People need a fully-working blood glucose meter so they can get an accurate reading and, if necessary, seek immediate medical attention.

“Blood glucose testing is an important part of diabetes management. People using these meters should ensure they follow the correct operating instructions when using them.

“If people have any questions about their blood glucose readings they should speak with their diabetes care team. Or they can contact the Accu-Chek® customer care line on 0800 701 000.”

Simon O’Neill, Director of Health Intelligence and Professional Liaison at Diabetes UK, said:

“It is really important for anyone testing to ensure they follow the instructions for their meter carefully as not doing so could give a false result and could result in inaccurate insulin delivery. If anyone has any concerns with using an Accu-Chek® meter they should discuss this with their diabetes healthcare team.”