Product Safety & Recall Information

URGENT MEDICAL DEVICE CORRECTION

FreeStyle Libre 3 and FreeStyle Libre 3 Plus Sensors

Issue: Abbott has identified that certain FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors provide incorrect low glucose readings. This issue does NOT apply to the FreeStyle Libre 3 reader and app or any other Libre product.

What You Must Do:

1. Check if your sensor is affected: Visit www.FreeStyleCheck.com to verify your sensor serial number. See how to locate the sensor serial number.
2. Verify expiration dates: Discard any sensors that have expired.
3. Use a backup method: Use a blood glucose meter or the built-in meter in your FreeStyle Libre 3 Reader to make treatment decisions when your sensor readings don't match your symptoms or expectations.

Potential Harms:

If undetected, incorrect low glucose readings over an extended period may lead to wrong treatment decisions for people living with diabetes, such as excessive carbohydrate intake or skipping or delaying insulin doses. These decisions may pose serious health risks, including potential injury or death, or other less serious complications.

Good News: Abbott has identified and resolved the cause of the issue. The company continues to produce Libre 3 and Libre 3 Plus sensors to fulfill replacement and new orders and does not expect significant supply disruptions.

Questions or Need Help?

• Contact Collins Medical Solutions: 203-576-8642
• Abbott Customer Service: 1-833-815-4273 (7 days/week, 8AM-8PM ET, 24/7 live chat available)
• Live Chat: Abbott Support

Report Adverse Events:

• Online: www.fda.gov/medwatch
• Phone: 1-800-332-1088 to request a reporting form
• Fax: 1-800-FDA-0178

URGENT MEDICAL DEVICE CORRECTION

TRUE METRIX, TRUE METRIX AIR and TRUE METRIX GO Self-Monitoring Blood Glucose Systems - E-5 Error Code Instructions

Consumer Notice:

Trividia is updating the E-5 Error Code in the Messages section of the Owner's Booklets/System Instructions for Use to emphasize that users must seek medical attention immediately if they receive an E-5 error code and are experiencing symptoms of high glucose.

The system displays an E-5 error code for a very high blood glucose event (greater than 600 mg/dL) or when there is a test strip error. As currently written, the instructions could potentially lead to a delay in treatment if the user does not seek medical attention immediately when they receive an E-5 error code and are experiencing symptoms of high glucose. A delay in treatment may result in serious adverse health consequences or death, especially for users with very high blood glucose levels.

UPDATED E-5 INSTRUCTIONS for TRUE METRIX, TRUE METRIX AIR, and TRUE METRIX GO:

Display: E-5

Reason: Very high blood glucose result (higher than 600 mg/dL), or Test Strip Error

Action:

WARNING!!
Retest with a new test strip.

If the error persists and you have symptoms such as fatigue, excess urination, thirst or blurry vision, seek medical attention immediately.

If you are not experiencing symptoms, retest with a new test strip. If the error persists, call 1-800-803-6025, Monday - Friday, 8AM-8PM EST for assistance.

Important: You may continue to use the TRUE METRIX Products. Products are not to be returned or replaced.

Questions? Contact Trividia Health Customer Care Department toll-free at 1-888-835-2723 Monday-Friday 8AM-8PM EST (excluding holidays) or email trividia0126CC@trividiahealth.com or visit www.trividiahealth.com/E-5productnotice