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

Help on accessing alternative formats, such as Portable Document Format (PDF), Microsoft Word and PowerPoint (PPT) files, can be obtained in the alternate format help section.

Contact: Marketed Health Products Directorate (MHPD)

---

The Health Products and Food Branch (HPFB) posts on the Health Canada web site safety alerts, public health advisories, press releases and other notices as a service to health professionals, consumers, and other interested parties. These advisories may be prepared with Directorates in the HPFB which includes pre-market and post-market areas as well as market authorization holders and other stakeholders. Although the HPFB grants market authorizations or licenses for therapeutic products, we do not endorse either the product or the company. Any questions regarding product information should be discussed with your health professional.

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^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 ^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 ^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 ^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:

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:
1. Gaines AR, Ross Pierce L, Patricia A. Bernhardt. Fatal Iatrogenic Hypoglycemia: Falsely Elevated Blood Glucose Readings with a Point-of-Care Meter Due to a Maltose-Containing Intravenous Immune Globulin Product. http://www.fda.gov/cber/safety/glucfalse.htm
2. Adverse Event Report in FDA-MAUDE: Roche Accu-Chek Comfort Curve Test Strips. www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.cfm?MDRFOI__ID=634797
3. Kroll HR, Maher TR. Significant hypoglycaemia secondary to icodextrin peritoneal dialysate in a diabetic patient. Anesth Analg. 2007; 104:1473-4.
4. Nienhuis WA, Bruijns RH, Vastenburg G, Wouters RS. Hypoglycaemic coma due to falsely elevated glucose values in a patient with diabetes mellitus and peritoneal dialysis. Ned Tijdschr Geneeskd. 2006; 150:1574-6.
5. Riley SG, Chess J, Donovan KL, and Williams JD. Spurious hyperglycaemia and icodextrin in peritoneal dialysis fluid. BMJ, 2003; 327:608-9.
6. Wens R, Taminne M, Devriendt J, Collart F, Broeders N, Mestrez F, Germanos H, Dratwa M. A previously undescribed side effect of icodextrin: overestimation of glycemia by glucose analyzer. Perit Dial Int. 1998; 18:603-9.
7. Slim S, Griffiths MJ, Gama R. Icodextrin - still a cause for concern with blood glucose monitoring in continuous ambulatory peritoneal dialysis patients with diabetes. Ann Clin Biochem. 2007; 44:196-7.
8. Octagam Monograph. Octapharma Canada Inc.
9. Cangene Corporation. HepaGamB: Hepatitis B Immune Globulin[Human] Injection with Conditions. http://www.hc-sc.gc.ca/dhpmps/
prodpharma/notices-avis/conditions/hepagamb_dhcpl_lapds_089393_e.html
10. Baxter: Extraneal (Icodextrin) Peritoneal Dialysis Solution. www.renalsource.com/extraneal/prescribinginfo.html
11. Kannan S, Rowland CH, Hockings GI, Tauchmann PM. Intragam can interfere with blood glucose monitoring. MJA. 2004; 180(5):251-2. http://www.mja.com.au/public/issues/180_05_010304/letters_010304_fm-3.html
12. Souza SP, Castro MCR, Rodriques RA, Passos RH, Ianhez LE. False hyperglycaemia induced by polyvalent immunoglobulin [letter]. Transplantation. 2005; 80(4):542-3.