FDA Warns of Potential Problems with Accuracy of Blood Glucose Meters from Abbott Diabetes Care

The Food and Drug Administration (FDA) is notifying health care providers and patients that blood glucose meters made by Abbott Diabetes Care can be accidentally switched from one unit of measurement to another thereby resulting in an inaccurate blood glucose reading.

An inaccurate reading of the meter can lead patients to take the wrong dose of insulin, which could cause high levels of sugar in the blood, known as hyperglycemia. Hyperglycemia can be life-threatening condition and several cases of hyperglycemia have been reported to FDA.

The meters report blood glucose levels in two different measurements milligrams per deciliter, or mg/dL, the U.S. standard, and millimoles per liter, or mmol/L, the foreign standard.

An unintentional switch in measurement may occur when a patient sets the time and date for the meter, or when it is dropped, or even after the replacement of the battery.

Patients in the U.S., therefore, must make sure their meter reading is displayed in the mg/dL format.

Instead of recalling the products, Abbot has issued a global correction and notification to all healthcare professionals and known users about the problem.

All Abbott glucose meters currently being shipped for distribution are locked with the correct unit of measurement.

The affected glucose meters made by Abbott that are sold in the United States are:

FreeStyle, FreeStyle Flash, FreeStyle Tracker, Precision Xtra, MediSense, Sof-Tact, Precision Sof-Tact, MediSense, Optium, Precision Sof-Tact meters, and private label brands ReliOn Ultima, Rite Aid, and Kroger blood glucose meters.

Affected glucose meters sold outside of the United States are: Xceed, Liberty, Boots, Xtra Classic, Easy, and SofTrac.

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.

Abbott’s products are distributed primarily through retail and mail order physicians’ offices and pharmacies.

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