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

Model Number	102096-67A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	07/07/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As per notes, the clamp slipped off the sensor and the cap came off which required another step to retrieve the cap.The entire sensor was removed, there was no harm to the patient and the sensor will be returned to senseonics for analysis.Rma-18452 was created for return of product without replacement.As per notes, user was doing fine.No further resolution was found necessary for this complaint.
Event or Problem Description
On (b)(6) 2022, senseonics was made aware of an adverse event where users sensor broke during the removal procedure.
Additional Manufacturer Narrative
Upon reception of the rma, a visual inspection confirmed the customer's complaint.Pictures do show that the end cap of the sensor popped off while it was being explanted.Though the end cap was not received in-house with the rma, the case note confirms that fragments of broken sensor were successfully removed.Bubbles were observed close to the cap interface.Forcep marks were visible on the edge of the sleeve where cap came off.Breakage of sensor during removal is a known and anticipated potential adverse effect, which does not require additional investigation.Per case notes, sensor fragments were successfully removed.There was no harm to the user.User is doing fine.No further resolution was found necessary for this complaint.H3.Device evaluated by manufacturer? yes.H6.Type of investigation updated to 10.

• 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
• Manufacturer (Section G): SENSEONICS INC.; 20451 seneca meadows parkway; germantown MD 20875 7005
• Manufacturer Contact: vallikannu somasundaram ; 20451 seneca meadows parkway; germantown, MD 20875-7005
• MDR Report Key: 15214474
• Report Number: 3009862700-2022-00125
• Device Sequence Number: 5633801
• Product Code: QHJ
• UDI-Device Identifier: 00817491022349
• UDI-Public: 00817491022349
• 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: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/14/2022

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: 102096-67A
• Device Catalogue Number: FG-4200-00-301
• Device Lot Number: WP08273
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2022
• Supplement Date Received by Manufacturer: 07/14/2022
• Initial Report FDA Received Date: 08/11/2022
• Supplement Report FDA Received Date: 08/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/20/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 20 YR
• Patient Sex: Female