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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 the actions users should take if an E-5 error code appears, particularly if they are experiencing symptoms of high blood glucose levels.
| Product image | Product Name | ARTG | Product Code |
|---|---|---|---|
| TRUE METRIX AIR | 288932 (cancelled) | REA4i81-11 |
| TRUE METRIX GO | 288932 (cancelled) | RF4i81-11BK
|
What is the problem?
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 device instructions do not clearly advise users to seek urgent medical attention.
What are the risks?
This problem could result in a delay in treatment, which could lead to serious health consequences or death, particularly for users with very high blood glucose levels.
What should I do?
- Review the updated error code instructions at 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.
Further information
Please contact the manufacturer, Trividia Health, Inc., on 1800 001 351 (Monday to Friday, 12:00 am-12:00 pm AEDT) for further information.
Reporting problems
Consumers and health professionals are encouraged to report problems with medical devices. Your report will contribute to our monitoring of these products. For more information see the TGA Incident Reporting and Investigation Scheme (IRIS).
The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medical device.