On (b)(6) 2023, senseonics was made aware of an adverse event where the user was admitted in hospital for diabetic ketoacidosis and hyperglycemia.On the day of event, when the user was at work she didn't feel well, and her bg measured at 6:05 am was 81 mg/dl.A few hours later, the user started having the symptoms of vomiting and blurry vision, which eventually led to the hospitalization where her bg was measured to be 681mg/dl around 9 am.After dms review it was confirmed that user didn't receive high glucose alerts at the times provided because the sg values didn't go above the high alert setting threshold.
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The user reported a hospitalization event where the user stayed at the hospital for two days due to a hypoglycemia event.From an associated complaint of sensor inaccuracy, it was observed that the user's past calibration entries were consistent with situations where estimated values provided by the app are used instead of the user's true bg values, which was confirmed by the user.Entering anything other than a true bg value can disrupt the calibration and lead to significant deviations in the sensor readings displayed, and this can have an impact for several days after resuming normal calibration.The user received treatment at the hospital with insulin and fluids.B4.Date of this report updated to 27 october 2023.G3.Date received by manufacturer 6 october 2023.H6.Investigation findings updated to 213.H6.Investigation conclusions updated to 18, 19.
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