MAUDE Adverse Event Report: SENSEONICS INCORPORATED EVERSENSE TRANSMITTER; CONTINUOUS GLUCOSE MONITOR

Model Number	102208-500
Medical Device Problem Code	Device Alarm System (1012)
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	04/23/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation of the data available in the data management system (dms) indicated the user was not using the eversense cgm system correctly.The user reported that she was entering default glucose values when prompted to calibrate the system instead of performing actual fingerstick measurements from a blood glucose meter as calibration entries because, per the user, she was not sufficiently informed on the calibration procedure.There were several manual glucose entries along with calibration entries, the calibration entries were marked as suspicious and the user stopped calibrating.Eventually the eversense cgm system re-entered the initialization phase due to the lack of the user properly calibrating.If calibrations are not successful, the system is designed to reset the glucose calibration by re-entering the initialization phase.As a result, the eversense cgm system was providing inaccurate glucose readings to the user.Once the user was instructed on proper calibration procedures, the system functioned as intended.There were no systemic malfunctions observed with the eversense cgm system.
Event or Problem Description
On april 25, 2019 senseonics was made aware of an adverse event where the user experienced a hyperglycemia event and reported the continuous glucose monitoring system did not alert her.The user required medical attention.

• Brand Name: EVERSENSE TRANSMITTER
• Common Device Name: CONTINUOUS GLUCOSE MONITOR
• Manufacturer (Section D): SENSEONICS INCORPORATED; 20451 seneca meadows parkway; germantown MD 20876 7005
• MDR Report Key: 8621541
• Report Number: 3009862700-2019-00015
• Device Sequence Number: 11295021
• Product Code: QCD
• UDI-Device Identifier: 00817491021458
• UDI-Public: 00817491021458
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: P160048
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 11/05/2019
• Device Model Number: 102208-500
• Device Catalogue Number: FG-3300-01-001
• Device Lot Number: 110552
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2019
• Initial Report FDA Received Date: 05/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other