On 28 october 2022, senseonics was made aware of an adverse event where user was hospitalized due to a high glucose event on (b)(6) 2022.During hospitalization user was treated with insulin via iv, no medication was prescribed after the event.User confirmed that he's doing fine and he is almost back to normal.
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The investigation did not reveal any malfunction with the sensor.However, it did reveal that the customer was not properly calibrating the system, which likely would have prevented the system from adjusting correctly for better accuracy, leading to missed adverse events.User was hospitalized where he was treated with insulin via iv.No medication was prescribed.Per case notes of associated sensor inaccuracies issue (complaintre(b)(6) ), user was educated on calibration best practices and was reminded to use true finger stick blood glucose (bg) value for calibration and not to enter estimated values shown by the system.No further resolution was found necessary for this complaint.D4.Updated additional device information.H3.Device evaluated by manufacturer?: yes.H4.Device manufacturer date updated to 04mar2022.H6.Investigation findings updated to 3250.H6.Investigation conclusions updated to 19.
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