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 Code	Hypoglycemia (1912)
Date of Event	05/07/2024
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 08 may 2024,senseonics was made aware of an incident where.User reports a low glucose event.The following example set was provided: 7-may-2024 between 10:00 pm - 11:00 pm ct | sg not available - bg 48 mg/dl.After dms review, we confirmed the following information at the time of the event: 7-may-2024 between 10:00 pm - 11:00 pm ct | sg not available - bg not entered the user didn't have glucose values available on that period of time because she had previously received a calibration past due alert at 6:37 am ct, and later a calibration expired alert at 10:08 pm ct, therefore low glucose alerts weren't available either.User didn't seek for medical treatment and resolved the event by taking a shot of insulin, eating and waiting around 15 minutes.User's hcp isn't aware of the event, user was advised to follow up with the hcp for further medical guidance.
Additional Manufacturer Narrative
The user originally reached out to report that she could not see glucose data in her system, as documented in e3 case, (b)(4).During troubleshooting, the user reported that she had experienced a hypoglycemic event the night before ((b)(6) 2024 between 10:00 pm and 11:00 pm) and had not been feeling well.The user reported that her bg at the time of the event was 48 mg/dl and sg value was not available because user had received a calibration past due alert at 6:37 am and later a calibration expired alert at 10:08 pm.The system could not trigger any alerts as the glucose values were blinded.User didn't seek any medical treatment and resolved the issue by taking insulin and eating.The user was advised to contact hcp for any medical guidance.No further investigation was found necessary for this complaint.B4.Date of this report 25 july 2024.H3.Device evaluated by manufacturer? yes.H6.Investigation findings updated to 114.H6.Investigation conclusions updated to 4315.

• 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: 19476033
• Report Number: 3009862700-2024-00726
• Device Sequence Number: 14470926
• 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): 07/25/2024

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: 07/24/2024
• Device Model Number: 102208-600
• Device Catalogue Number: FG-5900-01-001
• Device Lot Number: 139383
• 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: Not provided
• Supplement Date Received by Manufacturer: 07/25/2024
• Initial Report FDA Received Date: 06/06/2024
• Supplement Report FDA Received Date: 07/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/24/2023
• 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: Other
• Patient Age: 64 YR
• Patient Sex: Female