Notice

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Contact MDB Enquiries

November 7, 2005

Our file number: 05-123437-236

New Labelling Requirements for Glucose Monitors - Icodextrin Interference

The purpose of this notice is to communicate Health Canada's decision to request manufacturers of blood glucose monitors that show interference with peritoneal dialysis solutions to incorporate a warning clearly visible on the outer box label of the meter, in the User's Manual and in the package insert of the blood glucose test strips indicating that patients receiving peritoneal dialysis solutions containing icodextrin should not use the relevant device.

Health Canada issued an advisory on March 24, 2005, to alert health care professionals to cases of diabetic patient injury resulting from the interaction of icodextrin, used in peritoneal dialysis solutions, with certain brands of glucose monitors.

Glucose monitors based on the enzyme glucose dehydrogenase pyrroloquinolinequinone (GDH-PQQ) method are subject to this interference. As a result, patients with falsely elevated blood glucose readings may receive an excessive dose of insulin and a hypoglycemic episode could ensue or cases of hypoglycemia could go untreated if masked by glucose readings that are falsely elevated into the normal range.

A Health Device Alert issued in the United Kingdom on July 25, 2003 stated that during the past five years, 3 incidents, including 1 death were attributed to the overestimation of blood glucose levels using test strips based on GDH-PQQ in patients being treated with products containing maltose or metabolites of maltose.

In Australia, the Therapeutic Goods Administration in April, 2005 issued a safety alert on this issue due to the fact that they have received a small number of adverse event reports, including one death, resulting from undetected hypoglycemia in a peritoneal dialysis patient using GDH-PQQ based test strips.

Health Canada has also recently received 2 reports from a Canadian hospital of problems with falsely elevated glucose measurements in peritoneal dialysis patients using the aforementioned test strips.

As these incidents suggest that healthcare professionals and patients are still not adequately informed about this interaction, as an additional safety measure, Health Canada is now requiring that all manufacturers of blood glucose monitors that show interference with peritoneal dialysis solutions incorporate a warning clearly visible on the outer box label of the meter, in the User's Manual and in the package insert of the blood glucose test strips indicating that patients receiving peritoneal dialysis solutions containing icodextrin should not use the device.

Should you have any questions or require further clarification relating to this notice, please contact:

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

E-mail: MDB_Enquiries@hc-sc.gc.ca
Tel: (613) 954-0298
Fax:(613) 957-1596