A Diagnostics & Imaging Week

The FDA has issued a general notice concerning a problem with blood glucose meters made by Abbott Diabetes Care (Alameda, California).

It said that the meters could be mistakenly switched from one unit of measurement to another, thus producing an inaccurate blood glucose interpretation by the user.

It said U.S. users should make sure that their meter reading is displayed as milligrams per deciliter (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 the FDA.

The meters are designed to report blood glucose levels in two different measurements: the U.S. standard, mg/dL, and the foreign standard, millimoles per liter (mmol/L), and can accidentally be switched from one measurement to the other. The switch may occur when a user is setting the time and date for the meter.

The FDA also noted reports of the measurement being switched after a meter was dropped or after replacement of the battery. It said that Abbott has not confirmed these additional causes of failure.

Abbott is not instructing users to return their blood glucose meters. The firm issued a press release on Oct. 14, and has undertaken a worldwide correction and notification to all healthcare professionals and users, when known, about the measurement switching problem. All Abbott glucose meters currently being shipped for distribution are locked with the correct unit of measurement.

The affected glucose meters sold in the U.S. are: FreeStyle, FreeStyle Flash, FreeStyle Tracker, Precision Xtra, MediSense, Sof-Tact, Precision Sof-Tact, MediSense, Optium, and private-label brands ReliOn Ultima, Rite Aid and Kroger blood glucose meters. Precision Sof-Tact meters, which were inadvertently omitted from Abbott’s press release, also are subject to this action. These products are distributed primarily through retail and mail order pharmacies and physicians’ offices.

Affected glucose meters sold internationally include Xceed, Liberty, Boots, Xtra Classic, Easy and SofTrac.