Based on the investigation analysis, the reported event was at 3:14 pm est on (b)(6) 2023, where the calibration entry was marked as a suspicious calibration and the system prompted for additional calibration.The calibration entries before and after the reported event (10:35 am est and 7:14 pm) est were accepted by the system.The system adjusted the sensor reading upon completion of the calibration entry at 3:14 pm est, which is one of the mechanisms to adjust sensor readings based on calibration entry.Per the analysis of the associated sensor accuracy complaint, mdr report 3009862700-2023-00111, it was captured that the sensor (b)(6) was implanted in the same location as the previous sensor, where an infection was reported.This could be the potential cause, due to the sensor taking longer to stabilize after insertion.The user was reached out to ask if the incision site has healed.However, the user was unresponsive.Due to the deviation of the sensor performance and to determine the root cause, the rma was issued in the associated sensor accuracy complaint, mdr report 3009862700-2023-00111.The rma investigation will be captured as part of mdr report 3009862700-2023-00111.The user was inserted with a new sensor (b)(6) on (b)(6) 2023, which is performing within expectations.The user didn't seek for medical treatment and resolved the event by drinking some juice.Furthermore, as part of the resolution of mdr report 3009862700-2023-00111, for the issue with sensor inaccuracies, the user was offered a sensor replacement.No further resolution was found necessary for this complaint.H3.Device evaluated by manufacturer? yes.H6.Investigation findings updated to 114.H6.Investigation conclusions updated to 4315.
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