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.Patient reported that they get allergies every time a new sensor gets inserted, happening since the first insertion in 2019.The current sensor was patient's 10th sensor.The hcp told patient that it could be either due to lidocaine or insertion tools, sensor or adhesives (tegaderm and steri-strips).The hcp prescribed antihistamine and cortisone cream for prevention.The patient is still using the system with up to date glucose information.The patient was recommended to contact hcp for any medical assistance.This incident does not require any further investigation.
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Senseonics was made aware of an incident where patient reported allergic reaction every time a new sensor gets inserted, happening since 2019.The most recent sensor was inserted on (b)(6) 2023.The patient reported that they get allergic to everything, but nothing specific information was provided.The hcp said it could be related to lidocaine, tools, sensor or adhesives (tegaderm and steri-strips).Symptoms include redness and rash that spreads from her arm to her throat and disappears after three days.The hcp prescribed antihistamine tablets and cortisone cream for prevention.
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