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/swelling/pain/ inflammation/infection around the insertion site is a known anticipated adverse event.To alleviate the intense pain reported by the patient, the doctor prescribed augmentin (antibiotics).Although there was no signs of infection at the insertion site, the antibiotic course was prescribed as precaution and to reduce pain.The patient reported that the pain completely alleviated after taking antibiotics.The patient is currently using the eversense e3 cgm system with up to date glucose information.
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Senseonics was made aware of an incident where patient reported intense pain at the insertion site.Patient did not have any redness or swelling.Upon consulting the doctor, the patient was prescribed with antibiotics (augmentin).Although there was no sign of infection, the antibiotics was given as a precaution.The pain completely alleviated after completing the antibiotic course.
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