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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 Material Separation (1562)
Patient Problem Discomfort (2330)
Event Date 12/07/2023
Event Type  Injury  
Manufacturer Narrative
The next removal attempt has not been scheduled.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 the sensor broke in half and the hcp was unable to remove one of the pieces from the user's arm.
 
Manufacturer Narrative
Despite multiple follow up attempts with the user the removal status of the sensor could not be confirmed.Since the user was not responsive no further investigation is required.B4.Date of this report 25 april 2024.G3.Date received by the manufacturer? 25 april 2024.
 
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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 Key18504111
MDR Text Key332790416
Report Number3009862700-2024-00056
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 Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 04/25/2024
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 Date08/04/2023
Device Model Number102096-81A
Device Catalogue NumberFG-7200-00-301
Device Lot NumberWP09023
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 12/14/2023
Initial Date FDA Received01/12/2024
Supplement Dates Manufacturer Received04/25/2024
Supplement Dates FDA Received04/25/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured09/06/2022
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;
Patient Age62 YR
Patient SexMale
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