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

Model Number	102208-500
Medical Device Problem Code	Imprecision (1307)
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	02/02/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2022, senseonics was made aware of an incident where the user passed out and went to the emergency room due to low glucose results not detected by transmitter.
Additional Manufacturer Narrative
The manufacturer is currently performing an investigation and will provide the results with the supplemental report.
Additional Manufacturer Narrative
A review of the sensor's data showed that the system was being inaccurate around the date and time of the reported missed pm7 (hypo) event.The investigation revealed that the cause of the inaccuracy was the inappropriate calibration done by the customer a day before when he entered the sg values in the system for calibration, instead of bg values from his meter.No malfunction was found after the review of the sensor's key performance metrics.Per case notes, the user was taken to emergency room (er) where she was provided with an iv.User felt fine afterwards.User has stopped using the system based on dms and customer care was not able to reach the user since she has been unresponsive.No further resolution was possible.D9.Device available for evaluation? no.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: 13690641
• Report Number: 3009862700-2022-00039
• Device Sequence Number: 14704697
• Product Code: QCD
• UDI-Device Identifier: 00817491022516
• UDI-Public: 00817491022516
• 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): 02/05/2022

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: 03/11/2022
• Device Model Number: 102208-500
• Device Catalogue Number: FG-3302-01-001
• Device Lot Number: 123070
• 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: 02/05/2022
• Supplement Date Received by Manufacturer: 02/05/2022
• Initial Report FDA Received Date: 03/08/2022
• Supplement Report FDA Received Date: 03/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/11/2021
• 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: 67 YR
• Patient Sex: Female