Urgent Medical Device Correction

Last Updated: October 24, 2005

Abbott Issues Nationwide Urgent Medical Device Correction for Blood Glucose Meters

ALAMEDA, Calif., Oct.14, 2005 – Abbott Diabetes Care, a division of Abbott located in Alameda, Calif., is voluntarily initiating a correction and notification to users of its blood glucose meters in the United States. The products are sold under several model names in the United States including FreeStyle®, FreeStyle Flash®, FreeStyle Tracker®, Precision Xtra, MediSense® Sof-Tact™, and MediSense®; Optium™. Private label brands include ReliOn® Ultima, Rite Aid® and Kroger® blood glucose meters. Test strips are not affected by this correction.

Abbott Diabetes Care's blood glucose meters 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), a standard commonly used in other countries. The company has received consumer complaints that in the course of setting the time and date for their meters, users have inadvertently changed the units of measure from milligrams per deciliter (mg/dL) to millimoles per liter (mmol/L). This could lead to misinterpretation of test results with possible under-treatment and the potential for hyperglycemia. Abbott Diabetes Care has filed 17 medical device reports in the United States associated with this issue based on a U.S. user base of 2.25 million.

Consumers using Abbott Diabetes Care blood glucose meters may continue to safely use their meters and should verify that their meter is displaying the correct unit of measure each time they test. Consumers with questions may call Abbott Diabetes Care customer care at 1-800-553-4105.

Abbott Diabetes Care's blood glucose meters in the United States are distributed primarily through retail and mail order pharmacies, and physician offices. In order to ensure Abbott Diabetes Care customers only receive results in their country's standard, the company is taking several steps to eliminate any confusion, including: locking the meter's unit of measure with the standard of the country to which it is being shipped, revising meter manuals, and posting information to its web site, AbbottDiabetesCare.com.

Abbott is working with the U.S. Food and Drug Administration (FDA) to execute this voluntary medical device correction.

Related Resources

• Abbott Diabetes Care Customer Notification
  Urgent: Medical Device Correction (PDF 148KB)
  FreeStyle, FreeStyle Flash, Precision Xtra, MediSense Optium, MediSense Precision Sof-Tact,
  FreeStyle Tracker Blood Glucose Meters
   
• How To Set The Glucose Unit Of Measurement On Your Meter
  Note: The instructions below are excerpts from each of the following product Owner's Manuals.
  • FreeStyle® Blood Glucose Monitoring System (PDF 44KB)
  • FreeStyle Flash ® Blood Glucose Monitoring System (PDF 104KB)
  • FreeStyle Tracker® Diabetes Management System (PDF 47KB)
  • Precision Xtra Blood Glucose & Ketone Monitoring System (PDF 391KB)
  • Precision Sof-Tact Blood Glucose Monitoring System (PDF 391KB)
  • MediSense® Optium™ Blood Glucose Monitoring System (PDF 248KB)
  • ReliOn® Ultima™ Blood Glucose Monitoring System (PDF 248KB)
  • Rite Aid® and Kroger® Blood Glucose Monitoring System (PDF 248KB)
   
• Which Unit Of Measure Does My Country Use?
  When monitoring your blood glucose, always make sure that the glucose measurement units are set correctly, or you may misinterpret your blood glucose test results.

 

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