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

Model Number	102620-67A
Medical Device Problem Code	Failure to Sense (1559)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer is currently performing an investigation and will provide the results with the supplemental report.
Event or Problem Description
On july 13th 2020, senseonics was made aware of an incident where user received an early sensor replacement alert resulting in an early sensor removal.
Additional Manufacturer Narrative
No rma was received and hence no investigation is possible.D8 updated,was this device serviced by a third party? no h3.Device evaluated by manufacturer? no, not returned to manufacturer h6.Health effect - clinical code updated to 4582 h6.Health effect -impact code updated to 2199 h6.Medical device problem code updated to 1559 h6.Component code updated to 510 h6.Type of investigation updated to 4111 and 4114 h6.Investigation findings updated to 3221 h6.Investigation conclusions updated to 67.

• Brand Name: EVERSENSE SENSOR
• Common Device Name: EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM
• Manufacturer (Section D): SENSEONICS INC.; 20451 seneca meadows parkway; germantown, md
• MDR Report Key: 10391757
• Report Number: 3009862700-2020-00450
• Device Sequence Number: 3446625
• Product Code: QCD
• UDI-Device Identifier: 00817491022356
• UDI-Public: 00817491022356
• 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: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 08/29/2020
• Device Model Number: 102620-67A
• Device Catalogue Number: FG-4201-00-301
• Device Lot Number: WP07432
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/13/2020
• Supplement Date Received by Manufacturer: 07/13/2020
• Initial Report FDA Received Date: 08/11/2020
• Supplement Report FDA Received Date: 10/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 49 YR