Based on the investigation analysis, the reported events on february 4 and february 5, 2023, could not be confirmed as there was no corresponding calibration entry at the time.On february 7, 2023, at 12:51 pm est, the calibration entry of 66 mg/dl closely matched the sensor reading of 67 mg/dl at that time.The system displayed good agreement between the sensor readings and calibration entries during the time of the event.There were no hypoglycemia alerts asserted at the time because the sensor readings did not cross the low alert threshold of 60 mg/dl set by the user.The overall performance of the sensor, before and after the event, was within expectations.Per case notes, the user did not seek medical advice and was treated with sugar by her brother.The sensor is currently in use and the system is displaying good agreement between the sensor readings and calibration entries.No further resolution was found necessary for this complaint.H3.Device evaluated by manufacturer? yes.H6.Investigation findings updated to 114.H6.Investigation conclusions updated to 67, 4315.
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