Is Your Glucose Testing Reliable?

There are just some things that you hope you can trust. Medical devices for example. So it comes as a bit of a surprise to the diabetic community that the Food and Drug Administration (FDA) have just sent Abbott Diabetes Care a warning letter over quality controls at one of their plants.

The plant concerned is in Alameda, California and produces the FreeStyle Glucose Monitoring® and FreeStyle Navigator® Continuous Glucose Monitoring Systems for Abbotts.

Problems were picked up by the FDA in March 2010 and a notice was issued. Abbotts provided the FDA with an inadequate response and as a result they have now been issued with a formal warning letter that gives them 15 days to comply or further action may be considered.

Some of the most concerning issues raised are:

• Lack of product testing and quality control.
• Lack of sufficient personnel with the necessary education, background, training and experience to assure that all activities are correctly performed.

This must come as a bit of a blow to Abbott who succeeded in getting FDA approval for their new glucose test strips FreeStyle Lite® in May 2010 with expected widespread availability for the USA in August 2010. Of their innovation Heather L. Mason, senior vice president, Abbott Diabetes Care said

“By minimizing interference and providing a better testing experience, Abbott is delivering on what patients and health care professionals demand in diabetes care, especially for people who use insulin to manage their diabetes symptoms”

FreeStyle Lite® is not mentioned in the FDA warning letter.

If you use Abbott products it may well be worth seeking medical advice and switching to a different product until the issues have been resolved. Reliability of glucose testing kits is essential to the management of diabetes. The full article can be read here

Other Resources:

FDA warning letter

Abbott customer disruption notice

Blogs:

FDA Warning for Abbott – Diabetes Forums