ALAMEDA, Calif., July 20 /PRNewswire-FirstCall/ -- Abbott is reminding users of its FreeStyle(R) and FreeStyle Flash(R) blood glucose meters in the United States to check to make sure their meter is displaying the correct unit of measure (milligrams per deciliter, mg/dL) and strip calibration code each time they test.
Abbott previously communicated that in some cases, FreeStyle and FreeStyle Flash users could inadvertently change the units of measure on their meters when in set-up mode. More recently, it has been reported that in rare instances, the meter may become inoperable or may revert to a reset condition. This may occur when the meter is used for prolonged periods with the low battery symbol displayed. It may also rarely occur if batteries are defective. In the reset condition, the strip calibration code could change and units of measure may become selectable.
Abbott has issued a letter to health care professionals and all registered FreeStyle and FreeStyle Flash customers in the United States, notifying them of this rare possibility. The letter advises users to always check the correct strip calibration code at the beginning of each test and that the screen displays the correct unit of measure (mg/dl) with each test result. The letter also states, as referenced in the product labeling, that when the low battery symbol appears, the batteries should be replaced immediately.
The United States standard unit of measure is milligrams per deciliter (mg/dL). If the unit of measure is not set correctly, this could lead to misinterpretation of test results with possible under-treatment and the potential for hyperglycemia.
Patients using FreeStyle blood glucose meters may continue to safely use their meters. FreeStyle and FreeStyle Flash meter users do not need to return their meters. FreeStyle test strips are not affected by this notification.
Customers with questions may call Abbott Diabetes Care customer care at 1-800-233-6589. Abbott will provide a new replacement meter that includes new software and locked units of measure to any FreeStyle or FreeStyle Flash customer who requests one.
Abbott's blood glucose meters in the United States are distributed primarily through retail and mail order pharmacies, and physician offices. More information about this notification is available on the company's website, http://www.abbottdiabetescare.com/ .
About Abbott
Abbott is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs 65,000 people and markets its products in more than 130 countries.
Abbott's news releases and other information are available on the company's Web site at http://www.abbott.com/ .
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