Urgent Medical Device Correction - TRUE METRIX Systems
StayWell Insurance | February 25, 2026 | Maite, GU
Trividia Health, Inc. has issued an Urgent Medical Device Correction regarding updated instructions for the following blood glucose monitoring systems:
- TRUE METRIX
- TRUE METRIX AIR
- TRUE METRIX GO
- TRUE METRIX PRO (Professional Use)
What Is the Issue?
The E-5 error code displayed on these devices may indicate:
- A very high blood glucose level (over 600 mg/dL), or
- A test strip error
The current instructions in some Owner's Booklets and online guides may not clearly emphasize that immediate medical attention is required if an E-5 error appears and the user is experiencing symptoms of high blood sugar.
Delaying treatment in cases of very high blood glucose may result in serious health consequences, including:
- Severe dehydration
- Confusion or altered mental status
- Diabetic emergencies
- Death in extreme cases
Updated E-5 Instructions - TRUE METRIX, TRUE METRIX AIR, and TRUE METRIX GO
Display: E-5 error code
Reason:
Very high blood glucose result (higher than 600 mg/dL),
OR test strip error
Action:
- Retest with a new test strip.
- If the error persists and you have symptoms such as fatigue, excessive urination, thirst, or blurry vision, seek medical attention immediately.
- If you are not experiencing symptoms, retest with a new strip.
- If the error continues, call 1-800-803-6025 (Monday–Friday, 8AM–8PM EST) for assistance.
Updated E-5 Instructions - TRUE METRIX PRO (Professional Use)
Display: E-5 error code
Reason:
Very high blood glucose result (higher than 600 mg/dL),
OR test strip error
Action:
- Retest with a new test strip.
- If the error persists and you have symptoms such as fatigue, excessive urination, thirst, or blurry vision, seek medical attention immediately.
- If you are not experiencing symptoms, retest with a new strip.
- If the error continues, call 1-800-803-6025 (Monday–Friday, 8AM–8PM EST) for assistance.
Affected Products
This correction applies to certain NDCs associated with:
| Product | NDC |
|---|---|
| True Metrix Air Glucose meter (blood-glucose meter) |
FDB: 11917017389, 56151149002, 56151149102, 56151149403, 87701042739 Medispan: 11917017389, 56151149002, 56151149102, 87701042739, 56151149401 |
| True Metrix Blood Glucose meter (blood-glucose meter) |
FDB: 08528147401, 21292000605, 56151147002, 87701042625 Medispan: 56151147002, 87701042625, 11917016689, 50090558400, 50090558401 |
| True Metrix GO (blood-glucose meter) | FDB & Medispan: 56151195002 |
The following NDCs are also included as they were used to assist in identification of potential users of the affected devices.
| Product | NDC |
|---|---|
| True Metrix Glucose Test Strip (blood sugar diagnostic) |
FDB: 08528146404, 11917016690, 21292000616, 21292000618, 21292000619, 21292000717, 50428059453, 56151146001, 56151146003, 56151146004, 56151146101, 56151146104, 56151146304, 56151146401, 56151146404, 56151146704, 87701042626, 96295014204 Medispan: 11917016690, 50428059453, 56151146001, 56151146003, 56151146004, 56151146101, 56151146104, 56151146304, 56151146401, 87701042626, 96295014204, 50090355900, 50090240000, 50090246900, 08528146704 |
| True Metrix Pro Test Strip (blood sugar diagnostic) |
FDB: 21292000621, 56151146604 Medispan: 56151146604, 56151146601 |
| True Metrix Level 1 (blood glucose control, low) |
FDB: 56151145001, 21292000623 Medispan: 56151145001 |
| True Metrix Level 2 (blood glucose control, normal) |
FDB: 56151145002, 21292000624 Medispan: 56151145002 |
| True Metrix Level 3 (blood glucose control, high) |
FDB: 56151145003, 21292000625 Medispan: 56151145003 |
If you are currently using any TRUE METRIX monitoring system, please review the updated E-5 instructions.
Updated Owner's Booklets and help resources are available at: www.trividiahealth.com
For questions or to report concerns, please contact: Trividia Health
EMAIL: trividia0126CC@trividiahealth.com
PHONE : 1-888-835-2723
You may also report adverse events to the FDA MedWatch Adverse Event Reporting Program:
- Online: www.fda.gov/medwatch/report.htm
- Phone: 1-800-332-1088
- Fax: 1-800-FDA-0178