Based on the investigation analysis, estimated values provided by the app were entered as calibrations instead of the customer using their true bg values.Entering an estimated value or accepting the value from the eversense cgm system instead of entering a true, measured, bg value can disrupt the calibration and lead to significant deviations in sensor readings.The estimated bg values impacted the accuracy of the sensor readings and led to missing a potential medical adverse event.The user did not seek any medical attention and was able to self-treat for hyperglycemia.The user was educated about the importance of performing calibrations using true fingerstick bg values.Once the user understood the importance of proper calibration and the sensor passed the early wear adjustment period, the system began displaying good agreement between the sensor readings and calibration entries.User is currently using the system and no further investigation was found necessary for this complaint.H3.Device evaluated by manufacturer? yes.H6.Investigation findings updated to 213.H6.Investigation conclusions updated to 18.
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