URGENT MEDICAL DEVICE CORRECTION

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

The Products may continue to be used and sold.

Trividia is updating the description for the E-5 Error Code in the “Messages” section of the Owner’s Booklets (i.e., Instructions for Use), to highlight that users must contact their healthcare professional immediately if they receive an E-5 error message and are having diabetic symptoms. In such circumstances, as currently written, the E-5 error code description may potentially lead to a delay in treatment. In rare instances, a delay in treatment may result in serious adverse health consequences or death, especially for users with very high blood glucose (higher than 600 mg/dL).

UPDATED INSTRUCTIONS:

Display Reason Action
Very high blood glucose results (higher than 600 mg/dL), or Test Strip Error

WARNING!!!
Contact your Doctor or Healthcare Professional immediately if you have symptoms such as fatigue, excess urination, thirst, or blurry vision.

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.

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)

The correction affects all Products sold in the United States, UK, Mexico and the Caribbean, including co-branded products sold under 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
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)
Farmacias Del Ahorro (in Mexico)

WHAT YOU SHOULD DO:

Distributors: Please notify your customers immediately of this correction and include this letter in your notification. Complete and return the Acknowledgement form on page 3 of the PRODUCT NOTICE. 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 trividia0126CS@trividiahealth.com. Patients 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 and include this letter in your notification. Complete and return the  Acknowledgement form on page 3 of the PRODUCT NOTICE.
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 trividia0126CS@trividiahealth.com. Patients 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 4 of the PRODUCT NOTICE in areas where the Products are sold to advise patients of this labeling correction. Patients 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 patients who use these Products immediately of this correction. You may use the “URGENT MEDICAL DEVICE CORRECTION” consumer notice provided on page 4 of the PRODUCT NOTICE.
Patients 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 trividia0126CS@trividiahealth.com.

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 4 of the PRODUCT NOTICE.
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 trividia0126CC@trividiahealth.com  or visit trividiahealth.com/productnotice

    • FOR Multiple Patient Facilities: Please post the “URGENT MEDICAL DEVICE CORRECTION” HCP notice provided on page 5 of the PRODUCT NOTICE.
      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 4 of the PRODUCT NOTICE.
 If you are experiencing diabetic symptoms and you are receiving an E-5 error message, contact your healthcare professional immediately. 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)

This correction is being conducted in coordination with the U.S. Food and Drug Administration (“FDA”).

If you would like to view additional information, please click here for the PRESS RELEASE and the PRODUCT NOTICE.

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