This report is being submitted retrospectively as part of an internal review.Transmitter was the initial suspected device.However, preliminary investigation analysis revealed a deviation (from the normal behavior) in the sensor performance.The preliminary investigation was performed on the user's in vivo sensor data synced by the user on the data management system (dms), which is the data cloud platform for eversense systems.To further analyze the performance deviation and to determine the root cause of the malfunction, a return material authorization (rma) was authorized to bring back the sensor.But since the device was never returned.Hence no root cause analysis was possible.
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On october 12, 2022, senseonics was made aware of a hypoglycemia incident where patient complained of inaccurate sensor readings.Patient didn't provide a blood glucose reading but mentioned that the sensor glucose reading was 91 mg/dl.Patient did not receive a low glucose alert and was symptomatic.Patient had symptoms such as headache and blurry vision.Patient self treated with water and sugar.
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