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Main Category: Diabetes
Also Included In: Medical Devices / Diagnostics
The U.S. Food and Drug Administration (FDA) today advised health
care practitioners and patients against using certain glucose
monitoring technology that employs a specific test strip when the
patients are also receiving therapeutic products containing
non-glucose sugars.
Non-glucose sugars contained in some therapeutic products such as
peritoneal dialysis solutions and certain immunoglobulins can
falsely elevate glucose results, which may prompt excessive
insulin administration. These therapeutic products, which are
labeled to indicate that they may interfere with this particular
glucose monitoring technology, are mostly used in patients with
serious medical conditions, including kidney failure and moderate
to severe rheumatoid arthritis.
In a Public Health Notification and an accompanying Advice for
Patients, the FDA listed the manufacturers and brands of glucose
test strips that contain glucose dehydrogenase pyrroloquinoline
quinone (GDH-PQQ)-the chemical that reacts with the non-glucose
sugars (maltose, galactose and xylose) contained in some
therapeutic products that produce a falsely high test result.
Most GDH-PQQ devices are used in health care facilities, which
should instead use a laboratory assay to measure a patient's
glucose if the patient is also receiving an interfering product.
The FDA also makes recommendations to minize the risk of potential
shortages of these products until health care facilities can
obtain non-GDH-PQQ strips and meters.
FDA Public Health Notification: Potentially Fatal Errors with
GDH-PQQ Glucose Monitoring Technology
FDA Advice for Patients: Serious Errors with Certain Blood Glucose
Meters and Strips
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