| TGA Action ID |
RC-2026-RN-00166-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
TRUE METRIX Blood Glucose Monitoring Systems
TRUE METRIX AIR
Product Code: REA4i81-11
TRUE METRIX GO
Product code: RF4i81-11BK
ARTG 288932 (cancelled) |
| ARTG Number |
|
| Action Type |
Product Correction |
| Action Level |
Consumer |
| Hazard Classification |
Class I |
| Reason for the Action |
The former liquidator for Trividia Health Australia Pty Ltd (deregistered), is facilitating a product correction for TRUE METRIX Blood Glucose Monitoring Systems. This correction updates the instructions provided with the device to clearly explain what users should do if an E-5 error code appears and they are experiencing symptoms of high blood glucose levels (hyperglycaemia).
The system displays an E-5 error code for a very high blood glucose event (>33.3mmol/L) or when there is a test strip error. The current instructions do not clearly advise users to seek urgent medical attention in some situations. This could result in a delay in treatment, which could lead to serious adverse health consequences or death, particularly for users with very high blood glucose levels.
Since August 2014, when TRUE METRIX was launched globally, there have been 114 reported serious injuries, and one (1) death associated with the E-5 Error Code. No incidents have been reported in Australia in relation to this problem. |
| Instructions for Customers/Users |
Consumers are to:
- Review the updated error code instructions provided in the Customer Letter and on the Trividia Health Australia website (https://www.trividiahealth.com.au/).
As outlined in the instructions, if you see an E-5 error code:
- If you have symptoms of high blood glucose (fatigue, excess urination, thirst or blurry vision): seek medical attention immediately.
- If you do not have symptoms: retest using a new test strip. If the error continues, contact Trividia Health for assistance.
This action has been closed out on 10/04/2026 |
| Action Commencement Date |
10/03/2026 |
| Responsible Entity |
|
| Contact Information |
1800 001 351 - Trividia Health, Inc |