The FDA has issued a new warning regarding GDH-PQQ test strips, used in some glucose meters, giving inaccurate glucose readings. This is not the first warning the FDA has issued about these strips, but healthcare facilities have continued using them resulting in more deaths.
Monitoring Blood Sugar
Glucose meters are used to monitor blood sugar levels. When glucose is too high, insulin is administered to lower it. Hypoglycemia is the term for low blood sugar, or more accurately low blood glucose. Although we commonly refer to blood glucose levels as “blood sugar” levels, there are other types of sugar that can be present in the blood.
Controlling Blood Sugar
When blood sugar is too high for a prolonged period of time it can cause damage to blood vessels, leading to vision problems, heart disease, stroke, and nerve damage.
However, glucose is the body’s main energy source and the brain requires it to function. When blood sugar gets low the brain starts shutting down. Blood glucose levels can get so low as to cause seizures, coma, or death.
Symptoms of hypoglycemia include confusion, anxiety, blurred vision, sweating, abnormal behavior, and heart palpitations.
The Defect
Most test strips measure glucose levels. The GDH-PQQ test strips cannot distinguish glucose from other types of sugar. When other sugars are present in the blood the reading includes them, reporting a higher blood sugar level than the actual blood glucose level.
The Danger
This inaccurate result can mean failure to detect hypoglycemia or it can prompt health care providers to administer insulin when it is not appropriate. Either one can cause dangerously low blood glucose levels and can be fatal. So far, 13 deaths linked to the defect strips have been reported to the FDA.
Risk Factors
Sometimes medical patients are given products that contain non-glucose sugar as a part of their treatment. For instance, Extraneal is a solution used in dialysis treatment for people with kidney failure. It contains a type of sugar called icodextrin. Extraneal was being involved in 10 of the GDH-PQQ related deaths.
Recommendations
The FDA has warned about the dangers of GDH-PQQ test strips in the past, but healthcare facilities continue to use them and deaths are continuing to occur. Now the FDA is recommending that healthcare facilities stop using the strips altogether. For those who insist on continuing use of the defective test strips they recommend taking several precautions including determining if a patient is using products that contain non-glucose sugars, and if so, never using the GDH-PQQ strips to test their blood sugar levels.
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