Of Special Interest to Laboratorians/LabNet
MedSun: Newsletter #23, April 2008

FDA Reminds Healthcare Professionals About Falsely Elevated Glucose Levels

FDA is reminding healthcare professionals of the potential for life-threatening falsely elevated glucose readings in patients who have received parenteral products containing maltose or galactose, or oral xylose and are subsequently tested using glucose dehydrogenase pyrroloquinolinequinone (GDH-PQQ) based glucose monitoring systems. In patients undergoing peritoneal dialysis with drugs such as Extraneal (Icodextrin) falsely elevated glucose levels have been observed and acted upon with blood glucose monitoring devices and test strips that use GDH-PQQ based methods. Subsequent to several documented deaths and injuries requiring intervention that occurred previous to 2005 and 2006, label warnings were added to the drug(s) and to the meters.

This remains an ongoing interest to the FDA, as they have recently received a medical device report where a hospital patient, administered with Extraneal and tested using a GDH-PQQ based meter and test strip, was treated for a falsely elevated hyperglycemia and died of hypoglycemia.

For additional information:

FDA Office of In Vitro Diagnostics News Archive. FDA Reminds Healthcare Professionals About Falsely Elevated Glucose Levels.


FDA Center for Biologics Evaluation and Research. Important Safety Information on Interference With Blood Glucose Measurement Following Use of Parenteral Maltose/Parenteral Galactose/Oral Xylose-Containing Products.

Roche Diagnostics Safety Alert. ACCU-CHEK Blood Glucose Monitoring Systems – Reminder of Potential for Falsely Elevated Blood Glucose Readings Due to Drug Interferences.

______________________________________________

Reminder: Users of Blood Glucose Meters Must Use Only the Test Strip Recommended For Use With Their Meter

Background:

The US Food and Drug Administration, Abbott Diabetes Care, and LifeScan are aware of instances where incorrect results were obtained using LifeScan OneTouch® Ultra® test strips with Abbott Precision Xtra® meters. OneTouch® Ultra® test strips are not intended for use with Precision Xtra® meters, and doing so may lead to lower than expected blood glucose results. Similar problems can also occur if other brands and models of meters and strips are not used in proper combination.

It is important for users to understand that if they use a test strip that is not recommended for their meter, the device may fail to give results or may generate inaccurate results.

Recommendations:
Users of blood glucose meters should carefully read the Owner’s Manual and only use the test strips that are specified for that meter. As an additional check, the test strip inserts identify the blood glucose meters with which they should be used.

Healthcare providers and pharmacists should advise their patients to use only test strips that are compatible with their meter.


_____________________________________________

FDA's Office of In Vitro Diagnostics has cleared the following devices for marketing:

Here you can see new In Vitro Diagnostic Devices recently approved for marketing:

http://www.fda.gov/cdrh/oivd/

Click under the left hand column "Quick Links" on the link "New OIVD products (since 2/21/2008)"
______________________________________________

Additional Information:

Fatal Iatrogenic Hypoglycemia: Falsely Elevated Blood Glucose Readings with a Point-of-Care Meter Due to a Maltose-Containing Intravenous Immune Globulin Product
http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/ucm155099.htm

FDA Center for Biologics Evaluation and Research. Important Safety Information on Interference With Blood Glucose Measurement Following Use of Parenteral Maltose/Parenteral Galactose/Oral Xylose-Containing Products.
http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/ucm154213.htm

Users of Blood Glucose Meters Must Use Only the Test Strip Recommended For Use With Their Meter
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/InVitroDiagnostics/GlucoseTestingDevices/ucm162016.htm

Here you can see new In Vitro Diagnostic Devices recently approved for marketing
http://www.fda.gov/cdrh/oivd/


MedSun Newsletters are available at www.fda.gov/cdrh/medsun