MAUDE Adverse Event Report: SENSEONICS INC. EVERSENSE TRANSMITTER; EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM

Model Number 102208-500

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fever (1858); Nausea (1970); Vomiting (2144); Diabetic Ketoacidosis (2364)

Event Date 04/02/2021

Event Type  Injury  

Manufacturer Narrative

The manufacturer is currently performing an investigation and will provide the results with the supplemental report.

Event Description

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.

Manufacturer Narrative

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.

• Brand Name: EVERSENSE TRANSMITTER
• Type of Device: EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM
• Manufacturer (Section D): SENSEONICS INC.; 20451 seneca meadows parkway; germantown MD 20875 7005
• MDR Report Key: 11774599
• MDR Text Key: 249004062
• Report Number: 3009862700-2021-00068
• Device Sequence Number: 1
• Product Code: QCD
• UDI-Device Identifier: 00817491021441
• UDI-Public: 00817491021441
• Combination Product (y/n): Y
• PMA/PMN Number: P160048
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 04/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/18/2020
• Device Model Number: 102208-500
• Device Catalogue Number: FG-3300-01-001
• Device Lot Number: 116514
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/05/2021
• Initial Date FDA Received: 05/04/2021
• Supplement Dates Manufacturer Received: 04/05/2021
• Supplement Dates FDA Received: 05/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 63 YR