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	Hyperglycemia (1905)
Date of Event	12/08/2021
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 09 december 2021, senseonics was made aware of an incident where user received high reading with her glucometer ( hyperglycemia) due to inaccuracies in sensor readings.
Additional Manufacturer Narrative
The complaint was investigated, and the mismatch on (b)(6) 2021 at 11:27 am was confirmed.The investigation revealed that the inaccuracy was due to a sudden drop in both the on and off channels, affecting the glucose modulation.The root cause of such a behavior is potentially a delamination, which cleared a moment later, allowing the glucose response to get back to normal again.Per case notes of associated sensor inaccuracies case (b)(4), sensor is working fine.No further investigation was found necessary for this complaint.As per notes, user wasn't symptomatic and didn't seek medical treatment because she was able to solve the event by herself.H6.Investigation findings updated to 3224 and 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 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: 13200986
• Report Number: 3009862700-2022-00002
• Device Sequence Number: 11840995
• Product Code: QCD
• UDI-Device Identifier: 00817491021441
• UDI-Public: 00817491021441
• 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): 12/09/2021

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: 02/17/2022
• Device Model Number: 102208-500
• Device Catalogue Number: FG-3300-01-001
• Device Lot Number: 122683
• 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: 12/09/2021
• Supplement Date Received by Manufacturer: 12/09/2021
• Initial Report FDA Received Date: 01/08/2022
• Supplement Report FDA Received Date: 03/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/17/2021
• 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
• Patient Sequence Number: 1
• Patient Age: 51 YR
• Patient Sex: Female