FDA Warning Is Issued on Some Blood Sugar Tests

By Avera Latest Reply 2009-08-16 00:48:47 -0500
Started 2009-08-14 23:57:51 -0500

This is the most recent warning issued by the FDA. I will cut and paste the basics for you and if you want to know more, an article is also posted in the "News & Article" section.

"The Food and Drug Administration is warning diabetes patients that certain blood sugar tests can give inaccurate results in patients taking other medications. Public health regulators told consumers not to use certain glucose testing strips from Roche, Abbott Laboratories and other companies in *combination with dialysis and other biologic drugs.* According to the agency, those formulations can elevate blood sugar level results falsely, raising the risk of insulin overdose."

"The FDA noted that patients who are on dialysis or have recently had surgery are more likely to use drugs or therapies containing nonglucose sugars.

GDH-PQQ is an abbreviation for glucose dehydrogenase pyrroloquinoline quinone.

The safety alert named seven types of test strips for nearly 20 devices that use the GDH-PQQ methodology. These include:

ACCU-CHEK Comfort Curve test strips
ACCU-CHEK Aviva test strips
ACCU-CHEK Compact test strips
ACCU-CHEK Go test strips
Freestyle test strips
Freestyle Lite test strips
TRUEtest test strips
Abbott Diabetes Care Freestyle test strips

The FDA received reports of 13 deaths from 1997 to 2009 associated with false results in GDH-PQQ test strip reporting in healthcare facilities, noting serious patient injury, including hypoglycemia, neurologic deterioration, severe hypoxia, and coma, prior to death.

The FDA recommended patients continue to use blood glucose tests and the correct strips for a given glucose meter, but to discontinue use of GDH-PQQ meters and strips if using an interfering drug or therapy."

5 replies

mamaoak 2009-08-15 16:48:31 -0500 Report

thanks glad you put this on. did they give the lot numbers that are effected?

Avera 2009-08-16 00:48:47 -0500 Report

There should be a warning on the test strips concerning this already. Always read your warnings before using any product. It is just the brand name of test strips, not a certain batch of them.

lipsie 2009-08-15 12:11:05 -0500 Report


Thanks so much on this! I am confused though, I do use Freestyle Light myself..how do I know if I am one of these people…I am not on Dialysis but don't understand the other stuff. Please help, cuz now I am nervous! Thanks hun! Sheila