Based on the initial escalation analysis, the sensor took longer than usual to stabilize after insertion and caused temporary noise in the sensor readings.The rma was authorized for the return of sensor for further investigation.The sensor was tested in-house, but the failure mode could not be reproduced during the return product analysis testing.Hence, the return product investigation is inconclusive.This may occur in some instances where the failure mode that presents itself is in the body is not reproduced in the lab.The potential root cause may be due to lack of hydration of the hydrogel.As part of resolution, an rma was issued for sensor replacement.H3.Device evaulated by manufacturer? yes.H6.Type of investigation updated to 10.H6.Investigation findings updated to 114.H6.Investigation conclusions updated to 4307.
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