Diabetics warned about faulty glucose testing aidsManufacturers will replace affected meters
09 June 2006
The medicines watchdog is warning diabetics to be vigilant after it discovered a safety problem with certain blood glucose meters which could result in users overdosing on insulin.
The Medicines and Healthcare products Regulatory Agency (MHRA) has acted 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.
In the UK mmol/L is the unit of measurement for blood glucose measurements but blood glucose test results displayed in mg/dL are actually 18 times higher. This would mean that a result of 6 mmol/L would display as 108 mg/dL.
Blood glucose meters are used by people with type 1 diabetes to measure the amount of glucose in their blood.
The MHRA is concerned that this change in unit of measurement could lead users to think that the blood glucose result is high and lead to them altering their treatment regime. This could then lead to patients self-administering an insulin overdose and going into a hypoglycaemic coma.
Affected blood glucose meters include FreeStyle and FreeStyle Mini (previously known as TheraSense ) and MediSense Optium Xceed manufactured by Abbott Diabetes Care as well as LifeScan OneTouch, LifeScan InDuo and LifeScan PocketScan manufactured by LifeScan.
The MHRA say the manufacturers will replace, free of charge, affected meters with new ones for which the unit of measurement cannot be changed. In the meantime, diabetics should ensure that the meter reads in mmol/L every time they test. Batteries should be changed immediately when the low battery symbol appears.
Concerned patients should check the MHRA website for further information or contact their healthcare professional.