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

Model Number	102208-620
Medical Device Problem Code	Imprecision (1307)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	12/28/2022
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 (b)(6) 2022, senseonics was made aware of an adverse event where user experienced hyperglycemia symptoms due to inaccuracies in sensor readings and system did not alert the user.
Additional Manufacturer Narrative
The customer's complaint of event on (b)(6) 2022 couldn't be confirmed, as the reported mismatches could not be verified, and a review of the glucose data showed the system was displaying good agreement between the sensor readings and calibration entries during a 2-week time range before the reported date.In the associated s4 case (b)(4) for this event, the user indicated that he sometimes enters readings from the cgm as calibration.Inputting estimated bg values into the cgm can cause inaccuracies and customer care advised the user to only enter true finger stick bg values.The investigation did not reveal any discrepancy in the overall performance of the sensor.Per case notes, the user was able to self treat by eating soup.The user was advised to contact hcp for any medical assistance.In addition, the user was recommended to enter true finger stick blood glucose (bg) values for calibration for the cgm system to perform accurately (sf case # (b)(4)).No further resolution was found necessary for this complaint.H3.Device evaluated by manufacturer? yes.H6.Investigation findings updated to 213.H6.Investigation conclusions updated to 67.

• Brand Name: EVERSENSE TRANSMITTER
• 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: 16137824
• Report Number: 3009862700-2023-00011
• Device Sequence Number: 6817088
• Product Code: QHJ
• UDI-Device Identifier: 00817491022936
• UDI-Public: 817491022936
• 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): 12/28/2022

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: 03/10/2023
• Device Model Number: 102208-620
• Device Catalogue Number: FG-5902-01-001
• Device Lot Number: 129542
• 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: 12/28/2022
• Supplement Date Received by Manufacturer: 12/28/2022
• Initial Report FDA Received Date: 01/11/2023
• Supplement Report FDA Received Date: 04/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/10/2022
• 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: Other
• Patient Age: 66 YR
• Patient Sex: Male