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

Model Number	102620-67A
Medical Device Problem Code	Imprecision (1307)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This mdr is result of a retrospective review of complaints.The manufacturer is currently performing an investigation and will provide the results with the supplemental report.
Event or Problem Description
On (b)(6) 2020,senseonics was made aware of an incident where user experienced inaccuracies in sensor readings which leads to early sensor removal.
Additional Manufacturer Narrative
Per initial escalation analysis, after insertion, it was found that the msp fell below the failure threshold of 0.35.Even thought the msp was improving, it could not be confirmed if the msp would increase above the 0.35 before day 21 from insertion.Based on the initial analysis, the rma was authorized, due to poor customer experience during the first 21 days after insertion.The rma has not been received, therefore no further investigation could be performed at this time.H3.Device evaluated by manufacturer? no,not returned to manufacturer.H6.Type of investigation updated to 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 20875 7005
• MDR Report Key: 11227473
• Report Number: 3009862700-2021-00029
• Device Sequence Number: 14457383
• 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: 2020
• 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): 12/02/2020

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: 11/21/2020
• Device Model Number: 102620-67A
• Device Catalogue Number: FG-4201-00-301
• Device Lot Number: WP07591
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/02/2020
• Supplement Date Received by Manufacturer: 12/02/2020
• Initial Report FDA Received Date: 01/25/2021
• Supplement Report FDA Received Date: 02/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 33 YR