Possible interference of icodextrin, intravenous immunoglobulins, galactose and d-xylose with certain blood glucose meters - Notice to Hospitals

Starting date:

December 15, 2008

Posting date:

December 16, 2008

Type of communication:

Notice to Hospitals

Subcategory:

Medical Device

Source of recall:

Health Canada

Audience:

Healthcare Professionals

Identification number:

RA-170001825

Notice about Health Canada advisories

Notice to Hospitals

Health Canada Issued Important Safety Information on Possible interference of icodextrin, intravenous immunoglobulins, galactose and d-xylose with certain blood glucose meters

December 15, 2008

To: Hospital Chief of Medical Staff

Please distribute to the relevant Departments of Nephrology, Emergency Medicine, Internal Medicine, Endocrinology, Pharmacy, Diabetic Education Units and other involved professional staff and post this NOTICE in your institution.

Subject: Possible interference of icodextrin, intravenous immunoglobulins, galactose and d-xylose with certain blood glucose meters

Health Canada would like to bring to your attention the fact that some medical products may interfere with certain types of glucose monitoring systems and therefore may generate falsely elevated blood glucose readings^{Footnote 1-4}

The test strips of non-glucose-specific glucose meters employ glucose dehydrogenase pyrroloquinolinequinone (GDH-PQQ) or glucose dye oxidoreductase (GDO) enzymatic assays. Both enzymatic assays can react with other sugars such as maltose, galactose and xylose. Therefore, medical products which contain or are metabolised into maltose, galactose and xylose may induce falsely elevated blood glucose readings^{Footnote 5-7}. These products are used mainly in hospital settings and include, but are not limited to: intravenous immunoglobulin such as hepatitis B immune globulin injection, icodextrin peritoneal dialysis solution, galactose for tolerance test and d-xylose for tolerance test ^{Footnote 8-10}.

Glucose-specific monitoring systems employ dehydrogenase-nicotinamide adenine dinucleotide, glucose dehydrogenase flavin adenine dinucleotide, glucose oxidase, or glucose hexokinase enzymatic assays which react only to glucose as substrate. The readings of these systems are not affected in the presence of maltose, galactose and xylose, and therefore, these monitoring systems are not subjected to this notice.

Overestimation of blood glucose levels may result in inappropriate administration of insulin. Iatrogenic insulin induced hypoglycemia/coma and deaths have been reported in diabetics and non-diabetes patients as a result of falsely elevated glucose readings ^{Footnote 11-12}. Health Canada has received reports of falsely elevated glucose readings in patients with renal failure and who underwent icodextrin peritoneal dialysis.

In order to prevent falsely elevated glucose readings in healthcare settings associated with use of the non-glucose-specific glucose monitoring systems, Health Canada recommends the following:

• Identify monitoring systems that are susceptible to interference from sugars such as maltose, galactose and xylose by carefully reading the Instructions for Use, the package insert of the test strips, the box label or by consulting the manufacturer.
• Using glucose-specific monitoring systems in hospitals.
• Consider a glucose serum test in situations where the non-glucose-specific glucose meter readings do not coincide with the patient's clinical status.

Health Canada will continue monitoring the issue and provide updates if new safety information becomes available.

Managing marketed health product-related adverse incidents depends on health care professionals and consumers reporting them. Reporting rates determined on the basis of spontaneously reported post-marketing adverse incidents are generally presumed to underestimate the risks associated with health product treatments. Any cases of serious or unexpected adverse incidents in patients using blood glucose monitoring systems or other medical devices should be reported to the marketing authorization holder or to Health Canada at the following address:

Health Products and Food Branch Inspectorate

HEALTH CANADA

Address Locator: 2003D

Ottawa, Ontario K1A 0K9

Telephone: The Inspectorate Hotline 1-800-267-9675

The Medical Devices Problem Report Form and Guidelines can be found on the Health Canada web site.

For other inquiries related to this communication, please contact Health Canada at:

Marketed Health Products Directorate (MHPD)

E-mail: MHPD_DPSC@hc-sc.gc.ca

Telephone: 613-954-6522

Fax: 613-952-7738

References