The user reported sensor reading inaccuracies around 14 october 2022.Based on the initial escalation analysis, the sensor performance deviated from normal behavior.An rma was authorized for further investigation.Upon receipt of the sensor, the return product analysis testing was performed, however, the return sensor did not reveal any malfunctions.In an associated complaint (3009862700-2023-00239), the user's hcp reported an infection at the insertion site on (b)(6) 2022.This infection potentially could have impacted the sensor performance causing the reported sensor reading inaccuracy.As part of resolution, the user received a sensor replacement.B4.Date of this report updated to 11 april 2024.D9.Device available for evaluation? yes, device received on 03 march 2023.Date received by the manufacturer? 09 april 2024.H3.Device evaluated by manufacturer? yes.H6.Type of investigation updated to 10.H6.Investigation findings updated to 114.H6.Investigation conclusions updated to 4315.
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