Public Health Notification
The Food and Drug Administration (FDA) is warning patients with diabetes that they may get an inaccurate reading of their blood sugar levels from certain glucose test strips.
The strips in question are from Roche’s Accu-Chek Comfort Curve test strips and Abbott Lab’s Freestyle.
According to the FDA, they contain non-glucose sugars, which can give false elevated blood sugar results which in turn can lead to an overdose of insulin.
The problem appears to be the use of the testing strips with certain dialysis and immunoglobulins, taken by patients with kidney failure and rheumatoid arthritis. The interference with glucose monitoring test strips is stated on the label.
Over the past dozen years, the FDA has received 13 reports of death related to the use of glucose testing strips, reports the Associated Press.
Many of the problems reported have come from hospitals and nursing homes, but the FDA reports the products continue to be used despite the warnings.
"Six of the deaths have occurred since 2008 despite FDA's efforts to communicate the risk," the agency said and in a letter warned doctors and nurses to report problems with the glucose testing strips.
In some cases, patients experienced brain damage, coma, and confusion before death. Patients are warned never to use GDH-PQQ glucose meters or test strips if they are using drugs that contain sugars other than glucose.
Abbott, based in Chicago, reports it is working on an alternate version of the Freestyle and plans to have a market application into the FDA in the next 30 days.
Diabetes impacts nearly 24 million Americans, according to the American Diabetes Association, and is marked by insufficient levels or the inability of the hormone, insulin, to break down dietary carbohydrates so the blood sugar can be used for energy.
It’s estimated almost six million people are unaware they have the disease Diabetes is life threatening as high glucose in the blood can damage the eyes, kidneys, nerves or heart. #