URGENT MEDICAL DEVICE CORRECTION

Labeling Correction for all TRUE METRIX® brand of Blood Glucose Monitoring Systems

The correction involves the E-5 Error Code in the “Messages” section of the Owner’s Booklets/System Instructions for Use. The system displays an E-5 error code for a very high blood glucose event (> 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.

Trividia is updating the E-5 Error Code actions to emphasize that users must seek medical attention immediately if they receive an E-5 error code and are experiencing symptoms of high glucose. Trividia Health will notify users of additional mitigation strategies as needed.

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

UPDATED E-5 INSTRUCTIONS for TRUE METRIX PRO:

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

If you have any questions, please call Trividia Health Customer Care Department toll-free at 1-888-835-2723 Monday-Friday 8AM-8PM EST (excluding holidays)

This labeling correction affects all Products sold in the United States, United Kingdom, Mexico, Australia, and the Caribbean, including co-branded products sold under the following store or distribution partner names:

Co-Branded Product Names
Care One (Ahold)
CenterWell (Humana)
CVS
Discount Drug Mart
Foster & Thrive/Sunmark/Healthmart (McKesson)
Good Neighbor Pharmacy (Cencora)
HEB
Henry Schein
HyVee
Kroger
Leader (Cardinal Health)
McKesson (Med Surg)
Meijer
ProCure (WynnMed)
Publix
Relion (Walmart)
Rite Aid
Signature Care (Albertsons)
Top Care (TopCo)
Walgreens
Farmacias Benavides (in Mexico)

WHAT YOU SHOULD DO:

Distributors: Please notify your customers immediately of this correction. Include this letter in your notification and ask that they notify their customers or facilities if they have further distributed the Products. Complete and return the Acknowledgement form on page 4 of the CUSTOMER COMMUNICATION to confirm you have received this notice and have notified your customers. If you have any questions, please call Trividia Health Customer Service at 1-800-588-1685 Monday-Friday 8AM-5PM EST (excluding holidays) or e-mail [email protected]. Customers may continue to purchase and use the TRUE METRIX® Products. Products are not to be returned or replaced.

Pharmacists/DME Providers: Please notify your stores/providers immediately of this correction. Include this letter in your notification and ask that they notify their customers or facilities if they have further distributed the Products. Complete and return the  Acknowledgement form on page 4 of the CUSTOMER COMMUNICATION to let us know you have received this notice and have notified and/or posted the notice for your stores/locations.  If you have any questions, please call Trividia Health Customer Service at 1-800-588-1685 Monday-Friday 8AM-5PM EST (excluding holidays) or e-mail [email protected]. Customers may continue to purchase and use the TRUE METRIX® Products. Products are not to be returned or replaced.

    • FOR RETAIL PHARMACIES: Please post the “URGENT MEDICAL DEVICE CORRECTION” consumer notice provided on page 5 of the CUSTOMER COMMUNICATION in areas where the Products are sold to advise patients of this labeling correction. Customers may continue to purchase and use the TRUE METRIX® Products. Products are not to be returned or replaced.

Mail Order/eCommerce Providers: Please notify your customers who use these Products immediately of this correction. You may use the “URGENT MEDICAL DEVICE CORRECTION” consumer notice provided on page 4 of the CUSTOMER COMMUNICATION. Complete and return the Acknowledgement form on page 5 on the CUSTOMER COMMUNICATION to confirm you have received this notice and have notified your customers.

Customers may continue to purchase and use the TRUE METRIX® Products. Products are not to be returned or replaced. If you have any questions, please call Trividia Health Customer Service at 1-800-588-1685 Monday-Friday 8AM-5PM EST (excluding holidays) or e-mail [email protected].

Health Care Professionals: Please notify your providers and patients who use these Products immediately of this correction. You may use the “URGENT MEDICAL DEVICE CORRECTION” consumer notice provided on page 5 of the CUSTOMER COMMUNICATION.
Patients may continue to use the TRUE METRIX® Products. Products are not to be returned or replaced. If you have any questions, please call Trividia Health Customer Care Department toll-free at 1-888-835-2723 Monday-Friday 8AM-8PM EST (excluding holidays) or e-mail [email protected]  or visit trividiahealth.com/productnotice

    • FOR Multiple Patient Facilities: Please post the “URGENT MEDICAL DEVICE CORRECTION” HCP notice provided on page 6 of the CUSTOMER COMMUNICATION in areas where the Products are stored within your facility to advise personnel of this labeling correction. You may continue to use the TRUE METRIX® Products. Products are not to be returned or replaced.

People with Diabetes: You may continue to use the TRUE METRIX® Products. Products are not to be returned or replaced. Please follow the updated E-5 error message instructions in the consumer notice on page 5 of the CUSTOMER COMMUNICATION.
If you have any questions, please call Trividia Health Customer Care Department toll-free at 1-88-835-2723 Monday-Friday 8AM-8PM EST (excluding holidays)

Trividia Health has notified the U.S. Food and Drug Administration (FDA) of this action.

If you would like to view additional information, please click here for the:

PRESS RELEASE
CUSTOMER COMMUNICATION
LIST OF IMPACTED PRODUCTS

Click here to view updated TRUE METRIX, TRUE METRIX AIR and TRUE METRIX GO Owner’s Booklets

Click here to view updated TRUE METRIX PRO Owner’s Booklet

Patient safety is our top priority, and we apologize for any inconvenience this correction may cause you.