LWPES Members:
The FDA has re-issued an alert regarding glucometer test strips that use glucose dehydrogenase pyrroloquinoline quinine (GDH-PQQ) to measure whole blood glucose. This methodology for testing blood glucose can also detect non-glucose sugars most notably maltose, xylose, and galactose, causing falsely high or normal blood sugars in hypoglycemic patients receiving intravenous medications containing non-glucose sugars (see list below). There have been 13 reports of fatal hypoglycemia in patients receiving drugs containing non-glucose sugars using the glucometers with the GDH-PQQ methodology. All fatalities have occurred in healthcare facilities. Other methods for detecting blood glucose such as the glucose oxidase, glucose dehydrogenase nicotine adenine dinucleotide (GDH-NAD), or glucose dehydrogenase flavin adenine dinucleotide (GDH-FAD) only detect glucose thus do not give falsely normal or high blood glucose in the setting of hypoglycemia. Laboratory measurements of glucose also do not use the GDH-PQQ method.
The FDA recommends that healthcare facilities avoid 1) use of glucometers using the GDH-PQQ method (see list below), 2) use only laboratory-based methods for detecting blood glucose in patients receiving the interfering drugs, 3) educate staff and patients about the potential for interference from the medications, 4) periodically verify blood glucose results using the GDH-PQQ methodology with laboratory measurements of glucose.
For more information
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PublicHealthNotifications/ucm176992.htm
To report an adverse reaction to the FDA
https://www.accessdata.fda.gov /scripts/medwatch /medwatch-online.htm
List of medications that contain interfering non-glucose sugars:
- Extraneal (icodextrin) peritoneal dialysis solution
- Some Immunoglobulins: Octagam 5%, Gamimune N 5%***, WinRho SDF Liquid, Vaccinia Immune Globulin Intravenous(Human), and HepaGamB
- Orencia (abatacept)
- Adept adhesion reduction solution (4% icodextrin)
- BEXXAR radioimmunotherapy agent
- Any product containing, or metabolized into maltose, galactose or xylose.
List of GDH-PQQ Glucose Test Strips
The following test strips (with associated meters) use GDH-PQQ methodology as of August 2009:
Roche Diagnostics:
- ACCU-CHEK Comfort Curve test strips, for use with:
- ACCU-CHEK Inform meters [model 2001201]
- ACCU-CHEK Complete meters [models 200 and 250]
- ACCU-CHEK Advantage meters [models 888, 831, 850, and 768]
- ACCU-CHEK Voicemate meters [model 0009221]
- ACCU-CHEK Aviva test strips, for use with:
- ACCU-CHEK Aviva meters [models 525, 535, and 555]
- ACCU-CHEK Compact test strips, for use with:
- ACCU-CHEK Compact meters [model GF]
- ACCU-CHEK Compact Plus meters [models GP and GT]
- ACCU-CHEK Go test strips
- ACCU-CHEK Go meters [model GJ]
- ACCU-CHEK Active test strips
- ACCU-CHEK Active meters [models GG and GN]
Abbott Diabetes Care:
- Freestyle test strips, for use with:
- FreeStyle meters
- FreeStyle Flash meters
- FreeStyle Freedom meters
- Freestyle Lite test strips, for use with:
- FreeStyle Lite meters
- FreeStyle Freedom Lite meters
Home Diagnostics:
- TRUEtest test strips
- TRUEresult meters
- TRUE2go meters
Smiths Medical:
- Abbott Diabetes Care Freestyle test strips, for use with:
- CoZmonitor blood glucose module (for use with the Deltec Cozmo Insulin Pump)
Insulet:
- Abbott Diabetes Care Freestyle test strips, for use with:
- OmniPod Insulin Management System
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