This report is being submitted retrospectively as part of internal review.Even though senseonics requested the product to be returned back for evaluation, it was not returned.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 pain/irritation/inflammation/infection at the insertion site is a known anticipated adverse event.Furthermore, it was decided to remove sensor from the patient's arm to alleviate pain.
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