This report is being submitted retrospectively as part of internal review.Sensor (b)(6) was returned for sensor replacement alert with error code (ec1).Ec1 was first presented to the customer on 10th june 2023 (day 115 since insertion).Qc testing of the returned sensor revealed a loss of chemical performance.In-vivo data also showed diminished metric of sensor performance (msp) indicator value throughout the insertion period.The system correctly disabled the sensor due to performance failure, and the system's self-test functions are working normally.The root cause of such failures are attributed to sensor's hydrogel oxidation.As part of resolution, the rma was issued for sensor replacement.No further investigation was found necessary for this complaint.
|