ARCHIVED - Notice - Units of Measurement for Blood Glucose Meters sold in Canada

Contact: Device Evaluation Division

March 8, 2010
Our file number: 10-105247-499

Notice

Subject: Units of Measurement for Blood Glucose Meters sold in Canada

Application

This notice affects:

• manufacturers of blood glucose meters for sale in Canada

Context

The purpose of this notice is to communicate Health Canada's decision to license blood glucose meters and associated software that display results solely in millimoles per litre (mmol/L) for sale in Canada.

In Canada, the standard unit of blood glucose measure is mmol/L. In other countries, the standard unit of measure may be milligrams per decilitre (mg/dL). Some glucose monitors display their results only in mmol/L while other device models are capable of displaying their results in either unit of measure.

It has been shown that in some meters the displayed units of measure can be changed inadvertently if the device is dropped, the batteries are changed, or even without apparent cause. Results in mg/dL may be 18 times higher than the same results expressed in mmol/L. If diabetic patients overestimate their 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.

Three product-specific public communications have been issued by manufacturers in January 2006, September 2005 and April 2005. They have been posted on Health Canada's website. On August 17, 2006, Health Canada issued an advisory to diabetic patients about the risk of misinterpreting test results on blood glucose monitors.

Effective immediately, in order to avoid future device-related adverse events, Health Canada is requiring that manufacturers of blood glucose meters applying for a medical device licence in Canada demonstrate that:

• the meter reports blood glucose concentration only in units of mmol/L;
• the units of measure cannot be changed by the user or by any physical treatment of the meter, such as dropping the meter or changing the batteries;
• any software provided for use with the blood glucose meter must display results only in units of mmol/L.

Additional Information

For questions or additional information please contact:

Device Evaluation Division
Medical Devices Bureau
Therapeutic Products Directorate
Health Canada
Room 1605 Main Building
150 Tunney's Pasture Driveway
Address Locator 0301H1
Ottawa, Ontario
K1A 0K9

Telephone: 613-954-0297
Fax: 613-957-9969
email: meddevices-instrumentsmed@hc-sc.gc.ca