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

Model Number 102208-600

Device Problem Imprecision (1307)

Patient Problems Hyperglycemia (1905); Nausea (1970); Blurred Vision (2137); Diabetic Ketoacidosis (2364)

Event Date 08/25/2023

Event Type  Injury  

Event Description

On (b)(6) 2023, senseonics was made aware of an adverse event where the user was admitted in hospital for diabetic ketoacidosis and hyperglycemia.On the day of event, when the user was at work she didn't feel well, and her bg measured at 6:05 am was 81 mg/dl.A few hours later, the user started having the symptoms of vomiting and blurry vision, which eventually led to the hospitalization where her bg was measured to be 681mg/dl around 9 am.After dms review it was confirmed that user didn't receive high glucose alerts at the times provided because the sg values didn't go above the high alert setting threshold.

Manufacturer Narrative

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

Manufacturer Narrative

The user reported a hospitalization event where the user stayed at the hospital for two days due to a hypoglycemia event.From an associated complaint of sensor inaccuracy, it was observed that the user's past calibration entries were consistent with situations where estimated values provided by the app are used instead of the user's true bg values, which was confirmed by the user.Entering anything other than a true bg value can disrupt the calibration and lead to significant deviations in the sensor readings displayed, and this can have an impact for several days after resuming normal calibration.The user received treatment at the hospital with insulin and fluids.B4.Date of this report updated to 27 october 2023.G3.Date received by manufacturer 6 october 2023.H6.Investigation findings updated to 213.H6.Investigation conclusions updated to 18, 19.

• 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: 17805351
• MDR Text Key: 324107624
• Report Number: 3009862700-2023-00182
• Device Sequence Number: 1
• Product Code: QHJ
• 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: 10/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/18/2023
• Device Model Number: 102208-600
• Device Catalogue Number: FG-5900-01-001
• Device Lot Number: 131426
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/18/2022
• 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): Hospitalization
• Patient Age: 48 YR
• Patient Sex: Female