Notification and Statement

Important Notice!
Last Updated: November 14, 2005

 

Abbott Diabetes Care
Notification and Statement
Regarding Abbott Blood Glucose Meters that Utilize GDH-NAD and GDH-PQQ Enzyme Technology

The U.S. Food and Drug Administration has posted a Safety Alert for physicians, nurses and other healthcare professionals related to the potential for elevated glucose readings in patients who have received parenteral drug products during peritoneal dialysis therapy; a link to this alert is provided below. Peritoneal dialysis therapy is not routinely undertaken in the United States.

http://www.fda.gov/cdrh/oivd/news/glucosefalse.html

The GDH-PQQ enzyme method of glucose determination is not employed in Abbott's Precision, Optium or Sof-Tact blood glucose meters, they employ a different technology and enzyme to measure blood glucose, commonly known as GDH-NAD. However, Abbott's FreeStyle® blood glucose meter and FreeStyle Flash® blood glucose meter do employ the GDH-PQQ enzyme technology with may yield elevated blood glucose readings. Abbott has publicly communicated this information via all package inserts included with every FreeStyle meter or FreeStyle Flash meter.

Abbott's FreeStyle blood glucose meter package inserts include the following information.

 

Information for Healthcare Professionals:
FreeStyle Blood Glucose Test Strips give accurate results when the following limitations are observed:

• Do not use during xylose absorption testing
• Intravenous therapy solutions such as some immunoglobulin preparations and peritoneal dialysis solutions containing icodextrin or compounds of Galactose > 13 mg/dL or Maltose > 20 mg/dL may cause overestimation of blood glucose results.

 

For questions related to the issue outlined above, medical professionals or other interested parties may call Abbott Diabetes Care at 1-888-522-5226.

 

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