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Archive – Health Canada Advises Diabetic Patients Using Extraneal Peritoneal Dialysis Solution about the Risk of Falsely Elevated Blood Glucose Monitor Readings
- Starting date:
- March 24, 2005
- Posting date:
- March 24, 2005
- Type of communication:
- Advisory
- Subcategory:
- Medical Device
- Source of recall:
- Health Canada
- Issue:
- Important Safety Information, Usage
- Audience:
- Healthcare Professionals, General Public
- Identification number:
- RA-11000524
Health Canada is advising diabetic patients who use peritoneal dialysis solution containing icodextrin (Extraneal™) about the risk of injury from falsely elevated glucose monitor readings when using certain brands of glucose monitors.
Patients with falsely elevated blood glucose readings may receive an excessive dose of insulin, which could result in a hypoglycemic episode. Similarly, cases of hypoglycemia could go untreated if masked by glucose readings that are falsely elevated into the normal range. Patients who experience a hypoglycemic episode might feel unwell, confused, hungry, nervous, dizzy or irritable. If untreated a coma can ensue.
Peritoneal dialysis is used in patients with kidney failure. There are different solutions that can be used in this type of treatment. Currently, Extraneal™ peritoneal dialysis solution, manufactured by Baxter Corporation, is the only solution containing icodextrin that is approved for sale in Canada. In the body, icodextrin breaks down to simpler sugars which can interfere with some blood glucose tests to produce a falsely elevated blood glucose reading.
Health Canada advises patients who use peritoneal dialysis solutions with icodextrin to only use glucose monitors that are not subject to interference from icodextrin metabolites. Patients who have any concerns should first talk to their pharmacist, physician, diabetic education unit and peritoneal dialysis unit. Patients should contact the manufacturer to find out about a specific glucose monitor's susceptibility to icodextrin interference.
Health Canada also advises patients who use icodextrin to identify themselves via MedicAlert® products, such as bracelets and pendants, and to inform others involved in their care about this medical information.
Health Canada is continuing to assess this health issue and will provide the public with any new information.
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