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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 Problem Failure to Sense (1559)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/27/2024
Event Type  malfunction  
Event Description
On february 28, 2024, senseonics was made aware of an incident where the user received an early sensor replacement alert resulting in an early sensor removal.
 
Manufacturer Narrative
The manufacturer is currently performing an investigation and will provide the results with the supplemental report.
 
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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 Key18997189
MDR Text Key339134529
Report Number3009862700-2024-00580
Device Sequence Number1
Product Code QHJ
UDI-Device Identifier00817491023308
UDI-Public817491023308
Combination Product (y/n)Y
Reporter Country CodeGM
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 03/27/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/28/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date11/24/2023
Device Model Number101967-950
Device Catalogue NumberFG-4500-50-302
Device Lot NumberWP09146
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/18/2024
Date Manufacturer Received02/28/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured12/06/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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