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Reporting a Medication Error

Safety Issue With an At-Home Cholesterol Test Kit

Published October 18, 2023

At-home cholesterol test kits are used in the same way as home blood sugar (glucose) test kits. The cholesterol kits are sold over-the-counter and are used to monitor their cholesterol. The kit comes with a handheld meter and single-use test strips. A drop of blood is applied to the test strip, which is then inserted into the meter to provide the cholesterol level.

Figure 1. The PTS Diagnostics CardioChek Analyzer and PTS Panels Self-Test Strips

Our affiliate, ECRI, recently did an evaluation of four at-home cholesterol test kits. The evaluation involved volunteers checking how easy the test kits were to use by just following the manufacturer’s instructions. Results of the evaluation revealed a safety issue with one company's at-home test kits: the PTS Diagnostics CardioChek Analyzer and PTS Panels Self-Test Strips (Figure 1). If the strip is inserted backward into the meter, it will provide a result (e.g., “CHOL < 100 mg/dL”) instead of indicating an error. This incorrect information could lead to a misinformed choice about seeking care and potentially to missed treatment.

Upon this discovery, the manufacturer was notified of this safety issue. If you or a loved one uses this product, it is important to understand how to use it correctly. Ask your doctor or pharmacist to show you how to insert the strip. If you have concerns with the test results, follow up with your provider.

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