April 2006
Blood-glucose meters
Users could inadvertently change the unit of measure when setting the date and time. If that happens, test results could be misinterpreted, prompting diabetics, who rely on the devices, to make dietary changes or take the wrong dose of insulin, resulting in potentially life-threatening hyperglycemia.
Products: 2.25 million FreeStyle, FreeStyle Flash, FreeStyle Tracker, MediSense Optium, MediSense Sof-Tact, Precision Sof-Tact, and Precision Xtra units.They were also sold as private label or store brands, including ReliOn Ultima, Rite Aid, and Kroger. Some of the products have been on the market since 2002, according to the Alameda, Calif.-based manufacturer. Consumer Reports tested the FreeStyle and FreeStyle Flash for an August 2005 report on blood-glucose meters. We did not encounter any problem. The meters were distributed primarily through retail and mail-order pharmacies, and doctors’ offices. They are designed to allow patients to display one of two standard units of measure, either milligrams per deciliter (mg/dL), the U.S. standard, or millimoles per liter (mmol/L), used in Canada and other countries. The company has received 17 reports from consumers who said they unintentionally changed the unit of measure when setting the date and time.
What to do: Patients should continue to use their meters, but always verify the correct unit of measure. For information, go to www.abbottdiabetescare.com or call 800-553-4105. Abbott has stopped making glucose meters that allow multiple units of measure. New models will contain the unit of measure applicable in the country where they are distributed.
Users could inadvertently change the unit of measure when setting the date and time. If that happens, test results could be misinterpreted, prompting diabetics, who rely on the devices, to make dietary changes or take the wrong dose of insulin, resulting in potentially life-threatening hyperglycemia.
Products: 2.25 million FreeStyle, FreeStyle Flash, FreeStyle Tracker, MediSense Optium, MediSense Sof-Tact, Precision Sof-Tact, and Precision Xtra units.They were also sold as private label or store brands, including ReliOn Ultima, Rite Aid, and Kroger. Some of the products have been on the market since 2002, according to the Alameda, Calif.-based manufacturer. Consumer Reports tested the FreeStyle and FreeStyle Flash for an August 2005 report on blood-glucose meters. We did not encounter any problem. The meters were distributed primarily through retail and mail-order pharmacies, and doctors’ offices. They are designed to allow patients to display one of two standard units of measure, either milligrams per deciliter (mg/dL), the U.S. standard, or millimoles per liter (mmol/L), used in Canada and other countries. The company has received 17 reports from consumers who said they unintentionally changed the unit of measure when setting the date and time.
What to do: Patients should continue to use their meters, but always verify the correct unit of measure. For information, go to www.abbottdiabetescare.com or call 800-553-4105. Abbott has stopped making glucose meters that allow multiple units of measure. New models will contain the unit of measure applicable in the country where they are distributed.
