FDA PROVIDES NEW SAFETY DATA ON GLUCOSE METERS
The FDA recently issued a safety warning about Abbott Diabetes Care's glucose meters, explaining that these meters can unintentionally be switched from one unit of measurement to another, resulting in inaccurate blood glucose interpretation by the user. This warning comes a week after Abbott issued its own warning about the devices.
According to the agency, users of the device "should make sure that their meter reading is displayed as 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 FDA, the agency said.
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, 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, the agency said.