A review of the device's manufacturing records revealed that the sensor lot met all requirements including sterilization requirements for release.A subcutaneous pocket of 3mm - 5mm deep will be created under the skin and the sensor will be inserted in this pocket.If the insertion pocket is too deep and if the sensor is inserted, this would result in inconsistent or weaker connection with the transmitter, affecting the normal functioning.In this incident, the sensor was inserted on (b)(6) 2013 and since then the sensor connection with the transmitter was very weak resulting in frequent sensor disconnections ('no sensor detected' alerts).This was confirmed via a review of data management system (dms) which is an eversense cloud platform.The number of alerts varied from day to day, but mostly triggered in the morning and early afternoon.The customer was asked to perform a transmitter diagnostic upload for further investigation.In addition, placement tests were performed to confirm if the user was placing the transmitter correctly.The placement test resulted in poor signal when the transmitter is not pressed against the arm.A review of transmitter diagnostic log revealed a weaker signal strength between the sensor and the transmitter.It was hence determined that the sensor might have been inserted deeper than usual.The customer was recommended to consult with hcp regarding the removal of sensor.The most likely root cause of the issue is the procedural error from the inserting doctor.This incident does not require any further investigation.
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On (b)(6), 2023, senseonics was made aware of an incident where the patient was recommended to have their sensor removed because it was determined that sensor might have been inserted deeper than usual resulting in the frequent sensor disconnections.The sensor was inserted on (b)(6) 2023 and since then the patient received "no sensor detected" alerts very often.
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