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

Model Number 102208-600

Device Problem Imprecision (1307)

Patient Problem Hyperglycemia (1905)

Event Date 12/21/2022

Event Type  Injury  

Manufacturer Narrative

The manufacturer is currently performing an investigation and will provide the results with the supplemental report.

Event 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.

Manufacturer Narrative

The customer's reported mismatches on (b)(6) 2022 (day 3 after insertion) were confirmed.The review of the user synced data on dms data showed that the system was still adjusting.The investigation revealed that some of the customer's calibrations were entered during a period of rapid change in glucose, resulting in the calibration not being accepted and delaying the adjustment of the system, leading to transient mismatches as the ones reported.As recommended in the s4 case (b)(4), the customer understood the need of calibrating the system as prompted, when the glucose values are not changing rapidly.Once the sensor was out of the early wear adjustment period, the overall sensor performance was within expectations.No further investigation was found necessary for this complaint.As per notes, the user did not seek any medial attention and self resolved the event.In addition, the user was recommended to perform calibrations when the glucose is not changing rapidly.Per dms, user is currently using the system with up to date information and the current performance is within expectations.No further resolution was found necessary for this complaint.H3: device evaluated by manufacturer? yes.H6: investigation findings updated to 114.H6: investigation conclusions updated to 4315.

• Brand Name: EVERSENSE TRANSMITTER
• Type of Device: 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: 16212571
• MDR Text Key: 307764955
• Report Number: 3009862700-2023-00013
• Device Sequence Number: 1
• Product Code: QHJ
• UDI-Device Identifier: 00817491022912
• UDI-Public: 817491022912
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P160048
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/21/2022

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/17/2023
• Device Model Number: 102208-600
• Device Catalogue Number: FG-5900-01-001
• Device Lot Number: 129742
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/21/2022
• Initial Date FDA Received: 01/19/2023
• Supplement Dates Manufacturer Received: 12/21/2022
• Supplement Dates FDA Received: 04/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/17/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 48 YR
• Patient Sex: Male