08222017Headline:

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Jamie Sheller
Jamie Sheller
Attorney • (800) 883-2299

FDA Warning For Some Diabetic Testing Strips

2 comments

Recently, the FDA issued a warning regarding the use of certain types of glucose testing strips. According to the FDA, some of the strips can’t distinguish between maltose, xylose, galactose, and other sugars. Such problems can produce falsely high readings, leading to dangerous overdoses of insulin. High doses of insulin can cause severe injury or death. Due to these dangers, the FDA warns that patients using therapies that include nonglucose sugars should not use GDH-PQQ glucose test strips. Dialysis patients or those with recent surgeries are more likely to use therapies that contain nonglucose sugars.

From 1997-2009, 13 deaths associated with false results in GDH-PQQ test strips were reported to the FDA. Those reports came from healthcare facilities, and prior to death, the patients suffered hypoglycemia, neurologic deterioration, severe hypoxia, and coma. The FDA safety alert included the following types of testing strips: ACCU-CHEK Comfort Curve test strips, ACCU-CHEK Aviva test strips, ACCU-CHEK Compact test strips, ACCU-CHEK Go test strips, ACCU-CHEK Active Freestyle test strips, Freestyle test strips, TRUEtest test strips, and Abbot Diabetes Care Freestyle test strips.

2 Comments

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  1. Mike Bryant says:
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    With the growing numbers of people being diagnosed with this problem this is very important information to get out.

  2. Marteliza says:
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    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.