Development of infection at the sensor insertion site is a known and anticipated potential adverse effect.The sensor is inserted by making a small incision and placing it under skin, and potential for developing skin irritation/inflammation/infection at the insertion site is a known anticipated adverse event.User stated that he did not have the infection right at the insertion site, but rather around it.The user was prescribed antibiotics for infection and a new sensor was inserted into the opposite arm due to a previous issue with the old sensor's bg values being inaccurate.A review of the device's manufacturing records revealed that the sensor lot met all requirements including sterilization requirements for release.No further investigation is required.
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