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

Model Number	102208-600
Medical Device Problem Code	Imprecision (1307)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Hypoglycemia (1912); Convulsion/Seizure (4406)
Date of Event	08/07/2024
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 august 12, 2024, senseonics was made aware of an adverse event where the user reported two seizures one after the other due to low glucose, with blood coming out of her mouth, which led to the ambulance being called.Sugar water was given as treatment at the hospital, but there was no medication prescribed.
Additional Manufacturer Narrative
It was reported that the user experienced two seizures one after the other due to low glucose, with blood coming out of her mouth, and an ambulance was called.The event happened on (b)(6) 2024 at 6:15 am.The user also reported that they blacked out on (b)(6) 2024, which was documented in a separate case (mfr# 3009862700-2024-00918).The user provided the following information: (b)(6) 2024 6:15 am | sg not available - bg 52 mg/dl at around 6:37 am.A review of the data management system (dms) revealed that no sg or bg values were available between (b)(6) 2024, because the system was not being used.No low glucose alerts were provided as the user was not using the system, and no bg was taken at the time of the event.According to the case notes, it was not until later when the user was in the ambulance that the bg of 52mg/dl was taken.The user was not using the system because of pain on the sensor site when the transmitter was used.This was documented in a pm01 case (b)(4).Since the system was not in use at the time of incident and no sg readings were available, the complaint confirmation was not possible.The user was given sugar water as treatment at the hospital.The user's hcp was made aware of the event and no medication was prescribed.The user is currently using the system with up-to-date information.No further resolution was necessary for this complaint.B4.Date of this report updated to 25 september 2024.G3.Date received by manufacturer? 23 september 2024.H6.Type of investigation updated to 4109, 4112.H6, investigation findings updated to 213.H6.Investigation conclusions updated to 4310, 19.

• Brand Name: EVERSENSE TRANSMITTER
• Common Device Name: EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM
• Manufacturer (Section D): SENSEONICS INC.; 20451 seneca meadows parkway; germantown MD 20876 7005
• Manufacturer (Section G): SENSEONICS INC.; 20451 seneca meadows parkway; germantown MD 20876 7005
• Manufacturer Contact: vallikannu somasundaram ; 20451 seneca meadows parkway; germantown, MD 20876-7005
• MDR Report Key: 20186983
• Report Number: 3009862700-2024-00917
• Device Sequence Number: 20841241
• Product Code: QHJ
• UDI-Device Identifier: 00817491022912
• UDI-Public: 00817491022912
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• PMA/510(K) Number: P160048
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 09/25/2024

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: 09/19/2023
• Device Model Number: 102208-600
• Device Catalogue Number: FG-5900-01-001
• Device Lot Number: 132179
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2024
• Supplement Date Received by Manufacturer: 09/23/2024
• Initial Report FDA Received Date: 09/10/2024
• Supplement Report FDA Received Date: 09/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/19/2022
• Is the Device Labeled for Single Use? (Y/N): No
• 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 Age: 23 YR
• Patient Sex: Female