Senseonics was made aware of an incident where patient had issues linking the sensor with the transmitter.The patient did not get any signal with the sensor.Upon consulting the hcp, it was found that the sensor was still in sensor holder.The hcp confirmed that there was no issue with the insertion tool, but they did not check after the insertion procedure if the sensor remained inside the holder.
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This report is being submitted retrospectively as part of internal review.The inserting hcp confirmed that the sensor had remained inside the sensor holder of the insertion tool and it did not get implanted during the insertion procedure that took place on (b)(6) 2023.This was discovered after the patient was unable to link the sensor to the transmitter despite trying several times.The hcp admitted that it was the error from their end to not check if the sensor got implanted or it remained inside the holder.The hcp normally checks that, but forgot in this case.The hcp, however, confirmed that there was no issue with the insertion tool.Since there was no issue with the device or the insertion tool, no further investigation was found necessary for this complaint.As resolution, a new sensor will be inserted to the patient.
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