Medical Device Alert – Blood glucose monitors

Blood glucose monitors that are for home use are at risk of producing false low blood glucose level results.

It is the TRUEresult and TRUEtrack blood glucose test strips that are possibly producing these false results, which has triggered an MHRA Medical Device Alert.

If you use these devices, you should take heed of this warning, and contact a medical professional or doctor if you are concerned.

Action to be taken

Action starting from 17^th August 2016 are to be completed by 12th September 2016 by healthcare personnel managing patients who use these devices. They are to:

• Identify patients who use TRUEresult, TRUEresult twist, and TRUEtrack blood glucose meters;
• Advise patients to discontinue use of any blood glucose test strips with affected lot numbers;
• Return affected test strips to manufacturer for replacement;
• Ensure patients are aware of this information and that they have an alternative testing means, if required;
• Ensure the patient can continue to monitor their blood glucose effectively;
• Advise them to contact their healthcare professional if patients are concerned about their blood glucose readings when using this meter.

All device details that are producing the false results can be found on the Gov.uk website.

A Field Safety Notice has also been issued by the manufacturer in July 2016. This has happened because some vials in specific lots are not sealed properly, and this can affect the performance of the strips.

Source: https://assets.publishing.service.gov.uk/media/57a9de40ed915d097100004e/MDA-2016-014.pdf