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

Model Number	102208-510
Medical Device Problem Code	Imprecision (1307)
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	12/16/2019
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 dec 17th, 2019, senseonics was made aware of an incident where the user experienced a hypoglycemia event and the system did not alert the user.
Additional Manufacturer Narrative
Based on the investigation, the system did assert the low glucose alerts around 10:12 pm est when the user set low alert threshold was crossed.Per the investigation, the system functioned as designed.H6 result code updated to 213.H6 conclusion code updated to 67.

• Brand Name: EVERSENSE TRANSMITTER
• Common Device Name: EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM
• Manufacturer (Section D): SENSEONICS INC.; 20451 seneca meadows parkway; germantown, MD 20875 7005
• MDR Report Key: 9598001
• Report Number: 3009862700-2020-00026
• Device Sequence Number: 2499990
• 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
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2019

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: 12/08/2019
• Device Model Number: 102208-510
• Device Catalogue Number: FG-3301-01-001
• Device Lot Number: 111241
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/17/2019
• Supplement Date Received by Manufacturer: 12/17/2019
• Initial Report FDA Received Date: 01/16/2020
• Supplement Report FDA Received Date: 03/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 55 YR