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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 102096-81A
Device Problem Difficult to Remove (1528)
Patient Problem Discomfort (2330)
Event Date 06/17/2023
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) 2023,senseonics was made aware of an adverse event where user confirms that the sensor couldn't be found at the time of removal appointment and it wasn't removed.
 
Manufacturer Narrative
Despite multiple follow up attempts with the user, the removal status of the sensor could not be confirmed.No further investigation was found necessary.B4.Date of this report updated to 26 september 2023.G3.Date received by manufacturer updated to 03 august 2023.
 
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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 Key17358660
MDR Text Key319372468
Report Number3009862700-2023-00148
Device Sequence Number1
Product Code QHJ
UDI-Device Identifier00817491022950
UDI-Public817491022950
Combination Product (y/n)Y
Reporter Country CodeUS
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,Followup
Report Date 09/26/2023
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 Date05/12/2023
Device Model Number102096-81A
Device Catalogue NumberFG-7200-00-301
Device Lot NumberWP08882
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 06/19/2023
Initial Date FDA Received07/20/2023
Supplement Dates Manufacturer Received08/03/2023
Supplement Dates FDA Received09/27/2023
Was Device Evaluated by Manufacturer? No
Date Device Manufactured06/23/2022
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age64 YR
Patient SexMale
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