A review of the in-vivo data shows that on the date of reported missed hyperglycemic event, the sg of the customer was 151mg/dl; but no bg was entered into the system.The user didn't receive a high glucose alert because the sg value never reached above the high alert level.Although the customer's complaint was confirmed, the investigation did not find any malfunction with the sensor.The investigation found that the customer was not properly calibrating the system.During our review of calibrations since insertion, we observed symptoms consistent with situations where estimated values provided by the app were entered as calibrations rather than true bg values.Using false bg values for calibration leads the system to discrepancies which eventually cause inaccuracies.Please refer to sf case# (b)(4) where escalation response was provided to the user.As recommendation, user was advised to enter true finger stick bg measurements for calibration.No further investigation was necessary for this complaint.H4.Device manufacturer date updated to 28 jan 2022.H3.Device evaluated by manufacturer? yes.H6.Investigation findings updated to 114.H6.Investigation conclusions updated to 19.
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