The Medicines and Healthcare products Regulatory Agency (MHRA) has identified a safety problem with certain blood glucose meters which under certain conditions display the wrong units of measurement. This could result in an insulin overdose and hypoglycaemic coma.
The MHRA has issued advice following a number of reports of adverse incidents where the units of measurement displayed on affected blood glucose meters have changed from mmol/L to mg/dL. The units of measure may change if the meter is dropped, or if the battery is changed when the meter is switched on. There may also be some meters for which the units of measurement displayed can inadvertently be changed by the user.
Blood glucose test results displayed in mg/dL are 18 times higher than those expressed in mmol/L. For example, a result of 6 mmol/L would display as 108 mg/dL. The MHRA is concerned that this change in unit of measurement could lead users to think that the blood glucose result is high and thus alter the treatment regime. This could lead to patients self-administering an insulin overdose and going into a hypoglycaemic coma.
The manufacturer is planning a comprehensive meter replacement programme for all affected meters. Users can expect to be contacted by the manufacturer regarding this issue in early 2007.
In the meantime, the user should ensure that the meter reads in mmol/L every time they test.
Affected blood glucose meters include OneTouch? Ultra?, InDuo? and PocketScan? manufactured by LifeScan.
Similar action was taken in June 2006 by Abbott Diabetes Care for their FreeStyleTM, FreeStyle MiniTM and MediSense Optium XceedTM blood glucose meters.
Concerned patients should contact their healthcare professional and check the MHRA website www.mhra.gov.uk for further information.