Some point-of-care glucose meters and test strip combinations cannot differentiate glucose from other sugars (such as maltose, xylose and galactose) in the blood. In the presence of these other sugars, the meter will produce a falsely elevated reading, which can result in the inappropriate administration of insulin with resulting hypoglycemia, or in concluding that the patient has a normal blood glucose when he or she is hypoglycemic – a repeat blood glucose check with the same meter will not indicate the correct blood glucose, because the “other sugar(s)” will again be included in the reading. Both types of readings (over and underestimation) can lead to death or life-threatening events, including loss of consciousness, coma and neurological damage. While these “other sugars” can derive from a number of products (e.g., oral xylose, parenterals containing maltose or galactose), one source to note is the use of icodextrin (Extraneal™) for peritoneal dialysis, a metabolite of which is maltose.
Some glucose meter brands use a test strip that is sensitive to these “other sugars,” whereas other brands do not. Also, some brands of meters may be able to distinguish these “other sugars” from glucose, depending on which type of test strip is used. Baxter, the manufacturer of Extraneal™ (icodextrin), maintains a list of glucose meter/test strip combinations which indicates whether each combination will give correct glucose readings in the presence of “other sugars” in the blood. The list is country-specific, and the Country-Specific Glucose Monitor List for the United States can be accessed at http://glucosesafety.com/us/pdf/countryspecific_glucose_list.pdf.
The risk of these adverse events can be reduced for patients who have any of these “other sugars” in their blood by:
Using a glucose meter/test strip combination that does not read sugars other than glucose (that is, using a glucose-specific meter and test-strip combination).
(1) Using a glucose meter/test strip combination that does not read sugars other than glucose (that is, using a glucose-specific meter and test-strip combination).
(2) Using laboratory testing methods (e.g., a laboratory analyzer), rather than point-of-care glucose meters.
(3) Periodically verifying glucose meter results with laboratory testing methods.
(4) Including warnings in any computer-based order entry system or pharmacy database when products that may result in “other sugars” in the blood are ordered in a hospital or clinic setting.
For more information, see the Public Health Notification on the U.S. Food and Drug Administration (FDA) website at: http://www.fda.gov/medicaldevices/safety/alertsandnotices/publichealthnotifications/ucm176992.htm.