Why is Roche’s Accu-CHEK Glucose Meter still on the Market?

Between 1997 and 2009, the FDA received 13 reports of death associated with GDH-PQQ (glucose dehydrogenase pyrroloquinoline quinone) glucose test strips in which there was interference from maltose or other non-glucose sugars. Some of the reports indicated that hypoglycemia, confusion, neurologic deterioration, brain damage and coma occurred prior to death. The medical community sometimes refers to this as fatal iatrogenic hypoglycemia, and its reasonable to suspect that there are significantly more cases of hypoglycemia that go unreported or unidentified.

Back in August 2009, the FDA advised diabetic patients and their caregivers to NEVER use GDH-PQQ glucose meters or test strips if you are using drug products or therapies that contain certain sugars other than glucose. This is because strips that use GDH-PQQ react with certain non-glucose sugars, including maltose and produce a falsely high result. The FDA recommended that diabetic patients who use any of the drug products that contain certain non-glucose sugars should never use these products. These GDH-PQQ test strips include the following:

Roche Diagnostics – ACCU-CHEK Comfort Curve test strips – ACCU-CHEK Aviva test strips – ACCU-CHEK Compact test strips – ACCU-CHEK Go test strips
– ACCU-CHEK Active test strips
Abbott Diabetes Care – Freestyle test strips – Freestyle Lite test strips
Home Diagnostics – TRUEtest test strips
So, it came as a surpise last week, when I noticed an advertisement with a $10.00 coupon for the purchase of an ACCU-CHEK Aviva system with the purchase of ACCU-CHEK Aviva test strips. These are products that are purchased over the counter, and the real profit for the device manufacturer is not in the purchase of the monitor but the continued and repeated purchasing of the test strips. And its alarming to think that those consumers that have been purchasing these products for several months or years may not be aware of the updated warning since few consumers are diligent enough to re-read the labeling every time they use a product to see what changes may have taken place.

The questions remain, however, why do these products remain on the market and why have they not been recalled by the FDA when there are similar products that provide the same benefit WITHOUT the risk of maltose interference? These other glucose test strip methodologies are not affected by the presence of non-glucose sugars and never provide false readings. Why are we taking any chances with people’s lives when the risk of false readings can be avoided altogether?

Sometimes merely adding a warning to a product isn’t enough. If there’s no rational justification for the product remaining on the market due to the presence of safer and more effective products, a labeling change isn’t sufficient. Complete removal of the product from the marketplace is the only reasonable outcome.

Roche Diagnostics claims that patient safety is important; however, when it comes to these glucose monitoring devices and strips, its clear that profit is a more compelling interest. Going beyond the FDA -required labeling changes, Roche should voluntarily remove these products from the market and stop paying lip-service to the issue of patient safety.