Model Number 102208-500 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Fever (1858); Nausea (1970); Vomiting (2144); Diabetic Ketoacidosis (2364)
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Event Date 04/02/2021 |
Event Type
Injury
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Manufacturer Narrative
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The manufacturer is currently performing an investigation and will provide the results with the supplemental report.
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Event Description
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On april 05th 2021, senseonics was made aware of adverse event where patient was hospitalized on (b)(6) 2021 due to diabetic ketoacidosis and was discharged on (b)(6) 2021.
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Manufacturer Narrative
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The patient was discharged on (b)(6) 2021.User states that the transmitter did alert high readings.Investigation shows that customer was hyperglycemic in days leading up to the event.Although the investigation couldn't confirm the high glucose alert in dms, the customer did confirm that he received high glucose alert.Investigation found no evidence of malfunction and system performed as intended.H6: investigation findings updated to 213.H6: investigation conclusions updated to 44.
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Search Alerts/Recalls
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