Archived – Association of Icodextrin-Containing Peritoneal Dialysis Solutions with Falsely Elevated Blood Glucose Monitor Readings – Notice to Hospitals

Notice to Hospitals - Health Canada Endorsed Important Safety Information on Blood Glucose Monitoring Systems

March 23, 2005

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: Association of icodextrin-containing peritoneal dialysis solutions with falsely elevated blood glucose monitor readings

Health Canada is aware of cases of diabetic patient injury resulting from the interaction of icodextrin with certain brands of glucose monitors.^{Footnote 1},^{Footnote 2},^{Footnote 3},^{Footnote 4},^{Footnote 5} Further reports of recent Canadian incidents involving this interaction suggest that healthcare professionals and patients are still inadequately informed about this interaction.

Blood glucose monitoring is a major adjunct to the management of individuals with diabetes mellitus. The measurement systems used by glucose monitors are typically based on either glucose dehydrogenase or glucose oxidase methodology.^{Footnote 3},^{Footnote 6}

Icodextrin is a large molecular weight glucose polymer used in peritoneal dialysis solutions due to its ultra-high filtration capacity.^{Footnote 4} From the peritoneal cavity, icodextrin can move into the systemic bloodstream where it is metabolized by serum amylase into maltose (a glucose dimer) and other oligosaccharides.^{Footnote 5} Currently, Extraneal^TM (Baxter Corporation) peritoneal dialysis solution is the only pharmaceutical containing icodextrin that is approved for sale in Canada.

The accumulation of blood maltose via icodextrin metabolism is cause for concern in individuals who use blood glucose monitoring systems that are not glucose-specific. In these individuals, accumulated maltose and other icodextrin metabolites may interfere with some blood glucose tests to produce a falsely elevated blood glucose reading. For example, glucose monitors based on the enzyme glucose dehydrogenase pyrroloquinoquinone (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. Similarly, cases of hypoglycemia could go untreated if masked by glucose readings that are falsely elevated into the normal range.

In order to reduce the risk of poor glycemic control and its consequences in diabetics using peritoneal dialysis solutions containing icodextrin, Health Canada recommends the following:

• determine appropriate training measures for staff to increase awareness of this issue
• review procedures to follow in an emergency situation, especially with patients who are known diabetics and/or unconscious
• ensure that patients using icodextrin use only glucose-specific monitors that are not subject to interference from icodextrin metabolites; blood glucose monitoring systems using the enzyme GDH-PQQ should not be used; if in doubt about a specific glucose monitor's susceptibility to this interference, contact the manufacturer
• encourage users of icodextrin to identify themselves via MedicAlert^® products and to inform others involved in their care of this medical information
• support all blood glucose monitoring systems with a central laboratory reference method in cases where the glucose monitor readings do not coincide with the clinical picture

Health Canada continues to carefully assess this issue and will release further information as it becomes available.

Health Canada depends on health care professionals to report adverse events related to medical devices. Any serious and/or unexpected adverse incident related to medical devices should be reported to Health Canada at the following address:

Health Products and Food Branch Inspectorate
Health Canada
Address Locator: 3002C
Ottawa, Ontario K1A 0K9
Tel: The Inspectorate Hotline 1-800-267-9675

For other inquiries, please refer to contact information:
MHPD_DPSC@hc-sc.gc.ca
Tel/Tél: (613) 954-6522
Fax/Télé: (613) 952-7738

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

References

Footnote 1

http://agmed.sante.gouv.fr/htm/alertes/filalert/dv04031a.pdf

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Footnote 2

ECRI Health Device Alerts, 27 (A30), July 25, 2003.

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Footnote 3

Mehmet S, Quan G, Thomas S, Goldsmith D. Important causes of hypoglycemia in patients with diabetes on peritoneal dialysis. Diabet Med 2001; 18: 679-682.

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Footnote 4

Oyibo SO, Pritchard GM, Mclay L, James E, Laing I, Gokal R, Boulton AJM. Blood glucose overestimation in diabetic patients on continuous ambulatory peritoneal dialysis for end-stage renal disease. Diabet Med 2002; 19: 693-696.Riley SG, Chess J, Donovan KL, Wiliams JD. Spurious hyperglycaemia and icodextrin in peritoneal dialysis fluid. BMJ 2003; 327:608-609.

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Footnote 5

Riley SG, Chess J, Donovan KL, Wiliams JD. Spurious hyperglycaemia and icodextrin in peritoneal dialysis fluid. BMJ 2003; 327:608-609.

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Footnote 6

Review Criteria Assessment of Portable Blood Glucose Monitoring In Vitro Diagnostic Devices Using Glucose Oxidase, Dehydrogenase or Hexokinase Methodology (Draft Document), U.S. Food and Drug Administration, Feb. 28, 1997.

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