FDA Warns Against Use Of Pre-Owned Test Strips For Glucose And Warfarin

Federal health officials are warning the public to stop purchasing pre-owned glucose and warfarin test strips, due to a risk that they may result in infection or inaccurate readings that alter a patient’s dosage, increasing the risk of severe or life-threatening injuries.

The U.S. Food and Drug Administration (FDA) issued a pre-owned test strips warning on Monday, amid growing reports of patients suffering injuries or reporting inaccurate readings from pre-owned warfarin or glucose test strips designed to be used by patients at home.

Test strips are products used by individuals who monitor for diseases and health conditions such as diabetes or those with high risk of blood clots in the veins and arteries.

Individuals diagnosed with diabetes use test strips on a daily basis to measure their glucose levels, which has a direct effect on how much insulin they receive. Similarly, patients at risk of blood clots use test strips to obtain their International Normalized Ratio (INR), which is a measurement used to monitor individuals on warfarin therapy to determine if they are receiving sufficient doses.

Test strips are also used to monitor for appropriate levels of the anticoagulant warfarin, to ensure a sufficient dose is received to reduce the risk of blood clots, without causing bleeding problems.

The FDA is warning the millions of Americans who use test strips to monitor warfarin and glucose levels on a daily basis not to use pre-owned test strip kits, or test strips not authorized for sale in the U.S. due to the increased risk of infection or inaccurate test results.

Pre-owned test strips have a magnitude of potential adverse health consequences for users. Test kits may have been improperly stored since they departed from the manufacturer, leaving irregular humidity exposure to alter the results. Expiration dates may have been altered or ripped off the labels leaving them susceptible to inaccurate or false readings.

Users may also be at risk of infections from pre-owned test strips, as the prior owner may have accidentally transferred blood to the test strip vial.

Additionally, officials warned they have been monitoring a growing number of adverse events related to pre-owned test strips altering a patient’s dosage recommendations. An inaccurate test strip reading could lead to serious and potentially fatal outcomes.

Patients who suffer from a blood thinner medication error could experience blood clots, severe bleeding, red or brown urine, black or bloody stool, severe headache and stomach pain, joint pain, vomiting, coughing up blood, dizziness, easily bruising, internal bleeding, heart attack, or strokes that could be fatal.

Similarly, a patient who receives the incorrect amount of insulin may suffer from hypoglycemia which could result in seizures, loss of consciousness, coma and death.

Patients using test strips at home are encouraged to always purchase unopened vials of test strips for your designated meter through a trusted source, such as your local pharmacy or directly through the manufacturer.

Patients with questions about verified sources to purchase test strips may consult with their primary care doctor for assistance. To report a problem involving glucose or warfarin test strips, patients may contact the FDA at 1-800-FDA-1088 or report them online at MedWatch, the FDA Safety Information and Adverse Event Reporting program.