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 pain/skin irritation/inflammation/infection at the insertion site is a known anticipated adverse event.Furthermore, patient decided to get the sensor removed to alleviate pain.There is no malfunction associated with the device that led to this incident.
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