The sensor was tested in-house, and the review of investigation analysis revealed a loss of chemical performance, which confirmed the complaint.The in-vivo data confirms the complaint with diminished signal throughout the insertion period.The system correctly disabled the sensor when it detected the performance failure, and the system's self-test functions were working normally.The root cause of the performance failure was due to oxidation of the chemical component of the sensor.As part of resolution, a return material authorization was issued for sensor replacement.No further resolution was necessary for this complaint.H3.Device evaluated by manufacturer? yes.H6.Type of investigation updated to 10.H6.Investigation findings updated to 174, 3231.H6.Investigation conclusions updated to 4307.
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