FDA Issues Alert for Abbott Glucose Meters

Check the Meters' Setting, Says FDA and Abbott Diabetes Care

From the WebMD Archives

Oct. 28, 2005 -- The FDA and Abbott Diabetes Care are alerting doctors and patients about a possible problem with blood glucose meters made by Abbott Diabetes Care.

Abbott Diabetes Care, a branch of the company Abbott, isn't recalling the meters.

Patients may continue to safely use the meters, but they should check the unit-of-measurement display each time, says an Abbott news release.

If the meters are set to the wrong measurement unit, patients may misinterpret the meter's readings. That could lead them to mistreat their diabetes and possibly experience high blood sugar (hyperglycemia), a serious and potentially fatal condition.

Affected Products

The meters are sold under several names. In the U.S., Abbott's affected meters are:

  • FreeStyle
  • FreeStyle Flash
  • FreeStyle Tracker
  • Precision Xtra
  • MediSense
  • Sof-Tact
  • Precision Sof-Tact
  • MediSense
  • Optium
  • Private-label brands ReliOn Ultima, Rite Aid, and Kroger blood glucose meters

The meters are mainly available from doctors and through retail or mail-order pharmacies.

Affected models sold outside the U.S. are:

  • Xceed
  • Liberty
  • Boots
  • Xtra Classic
  • Easy
  • SofTrac

Test strips aren't affected, says Abbott.

Check the Display

The meters are designed to report blood glucose levels in two different measurements:

  • The U.S. standard, milligrams per deciliter or mg/dL
  • The foreign standard, millimoles per liter or mmol/L

"Users in the U.S. 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," says the FDA.

The meters can be accidentally switched from one measurement to the other, such as when someone is setting the meter's time and date.

"There also have been reports of the measurement being switched after a meter was dropped or after replacement of the battery. Abbott has not confirmed these additional causes of failure," says the FDA.

Need Help?

Unsure how to check the setting? Check the owner's manual, call Abbott Diabetes Care at (800) 553-4105, or check the company's web site.

If you think you may have been using the wrong read-out on your meter for a long time and are now worried about your health, contact your doctor, advises the FDA.

Continued

Abbott says it has filed 17 reports of problems with the devices in the U.S. out of its more than two million customers.

"Those were all inadvertent, user-initiated changes to the units of measure," Abbott spokeswoman Tama Antonia Donaldson tells WebMD.

She says "a few" of those 17 cases involved hyperglycemia in patients who misread their meters due to incorrect unit-of-measure settings. None of those cases were fatal, says Donaldson.

Abbott is addressing the problem. The meters' unit-of-measure is now being locked on the appropriate setting before shipment. The meters' manuals are also being revised, and information about the issue is being posted on Abbott's web site.

Report Problems

Doctors or patients who have experienced a problem with any of the affected glucose meters should report those problems to the FDA's MedWatch program and to Abbott Diabetes Care.

The FDA's MedWatch program can be reached by phone at (800) FDA-1088 (800-332-1088) or http://www.fda.gov/medwatch.

WebMD Health News Reviewed by Louise Chang, MD on October 28, 2005

Sources

SOURCES: News release, FDA. News release, Abbott Diabetes Care. Tama Antonia Donaldson, spokeswoman, Abbott Diabetes Care.
© 2005 WebMD, Inc. All rights reserved.

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