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Risks of Using TRUE METRIX Blood Glucose Monitoring Systems by Trividia Health: FDA Safety Communication
The FDA has issued the FDA Safety Communication “Risks of Using TRUE METRIX Blood Glucose Monitoring Systems by Trividia Health” to alert the public of risks associated with the use of TRUE METRIX devices and provide Agency recommendations to users of this device.
The FDA recommends that all TRUE METRIX users transition to an alternative method for testing their blood glucose (blood sugar) when possible. Users should continue testing their blood glucose and should not stop using their TRUE METRIX meter until they have an alternative method available for testing. Users who continue to use a TRUE METRIX device prior to switching to an alternative method should be aware that an E-5 Error Code may mean that they are having a very high glucose (>600 mg/dL) event or that they have a test strip error, in which case their blood glucose may be normal or may be dangerously low or high. Any user receiving an E-5 Error Code while experiencing symptoms of low or high blood glucose should immediately contact their health care provider for help in determining appropriate treatment options.
Questions?
If you have questions, contact the Division of Industry and Consumer Education.
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