This report is being submitted retrospectively as part of internal review.A review of the device's manufacturing records revealed that the sensor lot met all requirements including sterilization requirements for release.The sensor is inserted by making a small incision and placing it under skin and potential for developing skin irritation/pain/ inflammation/infection at the insertion site is a known anticipated adverse event.Furthermore, the sensor was removed from the patient's arm to alleviate the symptoms.Also, a new sensor was inserted to continue using eversense continuous glucose monitoring (cgm) system.
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