Patient Notice: Important Safety Update on TRUE METRIX® Blood Glucose Meters
We want to inform you about an important FDA‑classified Class I recall involving TRUE METRIX® Blood Glucose Monitoring Systems. This is the most serious type of recall because the issue may lead to incorrect blood glucose readings and could result in serious injury if not addressed.
Which devices are affected?
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The correction applies to all TRUE METRIX brand meters
What is the issue?
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These meters use the same E‑5 error code for two very different situations:
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- A very high blood glucose level (>600 mg/dL)
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A test strip error
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Because the same code appears for both, patients may:
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- Mistake a true medical emergency for a strip error and delay treatment
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Treat themselves for dangerously high glucose when their level is actually normal or low
What should you do now?
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Do NOT ignore an E‑5 error code.
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If you feel symptoms of high blood sugar and see E‑5, seek medical care immediately
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Recommendations (*) for Patients using TRUE METRIX Meters and their Caregivers:
- Users should continue testing their blood glucose and should not stop using their TRUE METRIX meter until they have an alternative available for testing.
- Users should consult with their health care provider or pharmacist to discuss options for transitioning to an alternative glucose monitoring system.
- Be aware that delayed recognition of extremely low or high blood glucose levels could increase the risk of serious health complications or delays in treatment.
- All TRUE METRIX users should seek an alternative method for testing their blood glucose, if possible, until corrected meters become available.
Your safety is our priority!
Accurate glucose readings are essential for your health. If you use a TRUE METRIX meter and have questions or concerns, please contact our Piedmont Health Services Phone: 1-888-200-7001 or Text: 1-704-471-6008. We can work with you to find an alternate device and supplies for testing your blood glucose. We are here to help you stay safe and supported.
