Health Canada Advises Diabetic Patients About The Risk of Misinterpreting Test Results On Blood Glucose Monitors

August 17, 2006

Health Canada is advising diabetic patients who use blood glucose monitors about the risk of misinterpreting their test results. When a blood glucose monitor displays a patient's test results in a different unit of measure than a patient is used to, this could lead to a misinterpretation of the results. If this is unnoticed, it could cause a patient to improperly manage their diet or diabetes medication to help control their blood glucose levels. Blood glucose monitors are devices used by patients and health care professionals to measure the blood sugar levels in patients. Many of these devices are portable and used at home by diabetics who draw a drop of blood by pricking their finger.

In Canada, the standard unit of blood glucose measure is millimoles per litre (mmol/L). In other countries, the standard unit of measure may be milligrams per decilitre (mg/dL), which is 18-times higher than the same results expressed in mmol/L. Some glucose monitors used in Canada display their results only in mmol/L. Other device models are capable of displaying their results in either unit ofmeasure.

The displayed units of measure could inadvertently be changed if the device is dropped, the batteries are changed, or even without apparent cause. If a diabetic patient overestimates the blood glucose reading, they might self-administer too much insulin, which could lead to dangerously low blood glucose levels and loss of consciousness or seizure.

Health Canada advises patients who use blood glucose monitors to review the instructions for use of their specific glucose monitor, paying attention to information about the units of measure displayed.

Patients who have any concerns are advised to talk to their pharmacist, physician or diabetic education unit. If patients have questions about their specific model of blood glucose monitor, they may also contact the manufacturer of the device.

This information update follows three previous product-specific public communications issued by manufacturers in January 2006, September 2005, and April 2005.