Abbott Diabetes Care, a division of Abbott located in Alameda, California, is initiating a correction and notification to users of its blood glucose meters in the United States. The products are sold under several model names in the United States including FreeStyle, FreeStyle Flash, FreeStyle Tracker, Precision Xtra, MediSense Sof-Tact, and MediSense Optium. Private label brands include ReliOn Ultima, Rite Aid and Kroger blood glucose meters. Test strips are not affected by this correction, stated a release here.
The company had received consumer complaints that in the course of setting the time and date for their meters, users have inadvertently changed the units of measure from milligrams per deciliter (mg/dL) to millimoles per liter (mmol/L). This could lead to misinterpretation of test results with possible under-treatment and the potential for hyperglycemia. Abbott Diabetes Care had filed 17 medical device reports in the United States associated with this issue based on a US user base of 2.25 million.
Abbott Diabetes Care's blood glucose meters are designed to allow patients to display one of two standard units of measure; either milligrams per deciliter (mg/dL), the US standard; or millimoles per liter (mmol/L), a standard commonly used in other countries, added the result.
Abbott is working with the US FDA to execute this voluntary medical device correction.