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

Model Number 102208-500

Device Problem Imprecision (1307)

Patient Problem Hypoglycemia (1912)

Event Date 01/04/2022

Event Type  Injury  

Manufacturer Narrative

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

Event Description

On january 5th 2022, senseonics was made aware of an incident where user experienced hypoglycemia due to inaccuracies in sensor readings.

Manufacturer Narrative

Based on the investigation analysis, the event that was reported on (b)(6) 2022 at 10:40 am pst (pacific standard time, user's local time) was on the day after insertion and the system was in initialization phase.At 1:41 am est (eastern standard time), the system displayed a sensor reading of 45 mg/dl.The reported fingerstick measurement of 91 mg/dl was not entered in the system as a calibration entry.Per the reported event, there was temporary mismatch between the sensor readings and fingerstick measurements.The hypo alert was asserted before the reported event.Further analysis of the sensor diagnostic data showed the sensor was settling after insertion and this caused some transient noise in the optical channel measurements.Once the sensor settled, the system displayed better agreement between the sensor readings and the fingerstick measurements.User didn't mention if he was symptomatic or if he solved the event by himself, but didn't require medical treatment or hospitalization.The system is displaying better agreement between the sensor readings and the fingerstick measurements.No further resolution was necessary for this complaint.H6.Investigation findings updated to 213.H6.Investigation conclusions updated to 67.

• 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: 13310571
• MDR Text Key: 284979104
• Report Number: 3009862700-2022-00014
• Device Sequence Number: 1
• Product Code: QCD
• UDI-Device Identifier: 00817491021441
• UDI-Public: 00817491021441
• 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: 01/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 05/17/2022
• Device Model Number: 102208-500
• Device Catalogue Number: FG-3300-01-001
• Device Lot Number: 124098
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/05/2022
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 43 YR
• Patient Sex: Male