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

Model Number	102208-510
Medical Device Problem Code	Device Alarm System (1012)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	10/13/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturer is currently performing an investigation and will provide the results with the supplemental report.
Event or Problem Description
On (b)(4) 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 did not require medical attention.
Additional Manufacturer Narrative
Upon review of the data in data management system (dms), the hyper alerts were asserted from 12:43 am est to 5:58 am est.There was no malfunction of the system and the system functioned as per design.Since there is no return material authorization (rma) issued, no further investigation can be performed.G1,2 contact information was updated h6 results code was updated to 213.H6 conclusion code was updated to 67.

• Brand Name: EVERSENSE TRANSMITTER
• Common Device Name: EVERSENSE CONTINUOUS GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): SENSEONICS INC; 20451 seneca meadows parkway; germantown MD 20876 7005
• MDR Report Key: 9328150
• Report Number: 3009862700-2019-00309
• Device Sequence Number: 2498162
• Product Code: QCD
• UDI-Device Identifier: 00817491021458
• UDI-Public: 00817491021458
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P160048
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2019

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 12/17/2019
• Device Model Number: 102208-510
• Device Catalogue Number: FG-3301-01-001
• Device Lot Number: 111495-B
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/17/2019
• Supplement Date Received by Manufacturer: 10/17/2019
• Initial Report FDA Received Date: 11/15/2019
• Supplement Report FDA Received Date: 07/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 30 YR