FDA Reports Correction for TRUE METRIX Blood Glucose Monitoring Systems
There is an issue with an error code that provides the same error for a very high blood glucose event and a test strip error.
Key Highlights
- - The recall affects TRUE METRIX, TRUE METRIX AIR, TRUE METRIX GO, and TRUE METRIX PRO blood glucose systems.
- - The E-5 error code can indicate either a dangerously high blood sugar level or a test strip error, leading to potential misinterpretation.
- - 114 injuries and one death have been associated with this device issue, emphasizing the severity of the safety concern.
- - Users are advised to review the updated instructions and labeling to understand the error codes correctly.
- - The FDA recommends that users seek immediate medical attention if they experience symptoms of high blood glucose.
