MAUDE Adverse Event Report: SENSEONICS INC. EVERSENSE SENSOR; Sensor, glucose, implanted, non-adjunctive use

Catalog Number	FG-7202-00-301
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hypoxia (1918); Pneumonia (2011)
Date of Event	06/05/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Senseonics was made aware of a serious adverse event wherre the patient collapsed at home and was taken to the er nonresponsive with labored breathing.He was admitted to icu for acute hypoxemic respiratory failure secondary to accidental drug overdose from applying 2 of his fentanyl pain management patches.After admission and a ct scan, patient was subsequently found to have pneumonia and pulmonary embolism.He was treated for pneumonia and embolism with medications.He was provided an iv heparin drip 0-50 units/kg/hr as needed (b)(6) 2025 and prescribed eloquis (apixoban 20mg bix x7 days and 5mg bid thereafter) for the pulmonary embolism.The respiratory failure was resolved prior to discharge and the patient will follow up with a pulmonologist and additional outpatient imaging in coming weeks.This event is unrelated to diabetes and the use of eversense cgm system.This is a non-device related serious adverse event and no further actions were found necessary for this complaint.
Event or Problem Description
Senseonics was made aware of a non-eversense device related serious adverse event where the patient was hospitalized for acutre hypoxemic respiratory failure.The patient was admitted to icu and was treated and was treated for pneumonia and embolism with medications.

• Brand Name: EVERSENSE SENSOR
• Common Device Name: Sensor, glucose, implanted, non-adjunctive use
• Manufacturer (Section D): SENSEONICS INC.; 20451 seneca meadows parkway; germantown 20876 7005
• Manufacturer (Section G): SENSEONICS INC.; 20451 seneca meadows parkway; germantown 20876 7005
• Manufacturer Contact: vallikannu somasundaram ; 20451 seneca meadows parkway; germantown 20876-7005
• MDR Report Key: 22408142
• Report Number: 3009862700-2025-00912
• Device Sequence Number: 8304217
• Product Code: QHJ
• UDI-Device Identifier: 00817491022974
• UDI-Public: 00817491022974
• 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: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/05/2025

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: 06/28/2025
• Device Catalogue Number: FG-7202-00-301
• Device Lot Number: WP09981
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2025
• Initial Report FDA Received Date: 07/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/11/2024
• 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
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown