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U.S. Department of Health and Human Services

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

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SENSEONICS INC. EVERSENSE SENSOR; EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM Back to Search Results
Model Number 101967-950
Device Problems Installation-Related Problem (2965); No Apparent Adverse Event (3189)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/14/2023
Event Type  Injury  
Manufacturer Narrative
A review of the device's manufacturing records revealed that the sensor lot met all requirements including sterilization requirements for release.A subcutaneous pocket of 3mm - 5mm deep will be created under the skin and the sensor will be inserted in this pocket.If the insertion pocket is too deep and if the sensor is inserted, this would result in inconsistent or weaker connection with the transmitter, affecting the normal functioning.In this incident, the sensor was inserted on 13 november 2023 and since then the patient received "no sensor detected" alerts very often.The issue started immediately after insertion.When the customer tries to establish the connection the placing the transmitter over the insertion area by following placement best practices, the connection loses upon making hand movements.The issue was escalated and a review of transmitter diagnostic log revealed a weaker signal strength between the sensor and the transmitter.It was determined that the sensor was inserted deeper than usual.The customer was recommended to consult with hcp regarding the removal of sensor.The most likely root cause of the issue is the procedural error from the inserting doctor.This incident does not require any further investigation.
 
Event Description
Senseonics was made aware of an incident where the patient was recommended to have their sensor removed because it was inserted too deep resulting in the frequent sensor disconnections.The sensor was inserted on (b)(6) 2023 and since then the patient received "no sensor detected" alerts very often.
 
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Brand Name
EVERSENSE SENSOR
Type of Device
EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM
Manufacturer (Section D)
SENSEONICS INC.
20451 seneca meadows parkway
germantown MD 20876 7005
Manufacturer (Section G)
SENSEONICS INC.
20451 seneca meadows parkway
germantown MD 20876 7005
Manufacturer Contact
vallikannu somasundaram
20451 seneca meadows parkway
germantown, MD 20876-7005
MDR Report Key18314257
MDR Text Key330328390
Report Number3009862700-2023-00831
Device Sequence Number1
Product Code QHJ
Combination Product (y/n)Y
Reporter Country CodeIT
PMA/PMN Number
P160048
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Other
Type of Report Initial
Report Date 12/12/2023
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 Date02/16/2024
Device Model Number101967-950
Device Catalogue NumberFG-4500-50-302
Device Lot NumberWP09240
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 11/20/2023
Initial Date FDA Received12/12/2023
Was Device Evaluated by Manufacturer? No
Date Device Manufactured02/21/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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