FDA Provides Important Safety Information on Blood Glucose Meters

The U.S. Food and Drug Administration (FDA) is notifying health care providers and patients of a problem with blood glucose meters made by Abbott Diabetes Care, Alameda, Calif. The meters can unintentionally be switched from one unit of measurement to another, resulting in an inaccurate blood glucose interpretation by the user. Users in the United States should make sure that their meter reading is displayed as mg/dL because an inaccurate reading can lead to taking the wrong dose of insulin or dietary changes, resulting in higher levels of sugar in the blood or hyperglycemia. Hyperglycemia can be a serious and even life-threatening condition and several cases of hyperglycemia have been reported to FDA. For information on how to change the meter reading back to mg/dl, users should refer to their Owner’s Manual or contact Abbott Diabetes Care at 1-800-553-4105 (open 24 hrs. per day) or AbbottDiabetesCare.com. Consumers who think they may have been using the wrong read-out on their meters for a long period of time and are now worried about their health should contact their doctors. Physicians and consumers who have experienced a problem with any of the affected glucose meters should report to FDA’s MedWatch program at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088), and to Abbott Diabetes Care.
http://www.fda.gov/bbs/topics/NEWS/2005/NEW01250.html