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Some blood-glucose test results could be wrong, FDA says

August 14, 2009 |  4:41 pm

Insulin If you've been using glucose test strips to monitor your blood-sugar levels, check the label and check your other medications. The Food and Drug Administration warned today that some of the strips could be inaccurate if people are taking medications that contain sugars other than glucose.

Some strips. Not all. The advisory targets those strips known as GDH-PQQ (for glucose dehydrogenase pyrroloquinoline quinone). Other types are fine. So for heaven's sake, don't simply stop testing your blood glucose.

In fact, most of the targeted strips are used in healthcare centers, but even so... this is something of which diabetics -- and their healthcare providers and caregivers -- should be aware.

Diabetics undergoing dialysis or who have recently had surgery are among those most likely to be affected. The FDA said in its warning that the strips can react with other types of sugars and produce a falsely high result. The patient could then take too much insulin. And as diabetics know, this could lead to low blood sugar, coma or death.

Here's the FDA warning about the products from Roche, Abbott, Home Diagnostics, Smiths Medical and Insulet Labs.  

Here's the agency's advice for patients, which lists details about the specific products.

And here's an AP story with additional context.

-- Tami Dennis

Photo: Insulin is necessary. But too much can be fatal.

Credit: Los Angeles Times

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Comments (5)

It is important to have safe glucose monitors and test strips for correctly reading the diabetic patient’s blood glucose level. False readings, either higher or lower than normal, are dangerous with possible fetal outcomes.

It is even more important for my prospective campaign on annual or semiannual series of blood glucose for every individual. This series of tests taken immediately before and a two-hour course at 15-minute intervals after meal will help individual evaluate the state of his well being, educate him about the potential risk of diabetes mellitus by his carbohydrate-rich diet, and prevent him from becoming diabetic by healthy dieting.

I neither am nor was a diabetic. In the experimentations on my body since the middle of 2002, I have come to realize that the daily repeated spikes of high blood glucose after eating carbohydrates are dangerous to my health and the potential causes of acute and chronic diseases including acute heart attack and stroke. Hence, providing the public with accurate and safe blood glucose monitors and test strips is critical for preventive medicine.

Robert Su, M.D.

This is quite a surprise. That big names including Roche would have products that aren't reliable.

It is good that the FDA is on its toes and watching out for the consuming public. Warnings on such deficiencies are very important.

As a Type-1 diabetic for 25 years, I must check my blood sugar levels every two hours. I have no other alternative but to rely on these numbers; the test result allows me to precisely determine how much insulin I must inject whenever I eat and each night before I go to sleep. I have used Accu-Check meters and the very expensive glucose testing strips and found them highly inaccurate and very capable of error. I have reported my problems to the the number on the back of the meter and a polite but clueless telephone rep will suggest you to get a new box of strips, change your battery, or, they will send you a new meter, (I am on my 6th new meter this year alone). I can check my blood sugar at the same time on three different fingers and get three different test results. Try it yourself. THIS IS UNACCEPTABLE, FOLKS! Especially when those simultaneous test results range so broadly, 20-40 or more mg/dl difference, could result in an erroneous insulin dosage that could take a diabetic to the great hypoglycemic beyond

Simple solution for anyone concerned - switch to a Bayer Contour or a One Touch blood glucose meter so you don't have to worry about this ... not sure why this isn't mentioned as a solution in the article. Those companies will provide free meters to any person with diabetes. I use a Contour and it is very accurate.

Thank you for prominently featuring this vital notice. The included links are very useful. We write extensively about related issues at http://dentistryfordiabetics.com/blog, especially the links between elevated blood sugar and gum disease that can interfere with diabetes control and significantly increase risk of serious health events such as heart attack, stroke and blindness.

- Charles Martin, DDS
Founder, Dentistry For Diabetics



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