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

Model Number	102620-67A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	06/29/2021
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 june 29th 2021, senseonics was made aware of an adverese event where a horrible infection has been developed in patient's arm where the sensor was removed from and patient was admitted in emergency room.
Additional Manufacturer Narrative
H10: additional manufacturer narrative updated to,"development of infection at insertion site is a known and anticipated potential adverse effect, which does not require additional investigation per ntf-0282.Per case notes, the sensor had already been removed from the patient's arm on (b)(6) 2021 due to early sensor retirement.The infection was developed post sensor removal.No further information could be gathered due to lack of response from the user".D6b: explanted date updated to (b)(6) 2021.

• Brand Name: EVERSENSE SENSOR
• Common Device Name: EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM
• Manufacturer (Section D): SENSEONICS INC.; 20451 seneca meadows parkway; germantown MD 20875 7005
• MDR Report Key: 12243681
• Report Number: 3009862700-2021-00096
• Device Sequence Number: 20375482
• Product Code: QCD
• UDI-Device Identifier: 00817491022356
• UDI-Public: 00817491022356
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• PMA/510(K) Number: P160048
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/29/2021

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 11/05/2021
• Device Model Number: 102620-67A
• Device Catalogue Number: FG-4201-00-301
• Device Lot Number: WP08273
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/29/2021
• Supplement Date Received by Manufacturer: 06/29/2021
• Initial Report FDA Received Date: 07/29/2021
• Supplement Report FDA Received Date: 08/11/2021
• 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
• Patient Age: 23 YR