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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 Device Sensing Problem (2917)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/25/2024
Event Type  malfunction  
Manufacturer Narrative
The manufacturer is currently performing an investigation and will provide the results with the supplemental report.
 
Event Description
On march 25, 2024, senseonics was made aware of an incident where the user received multiple sensor suspend alerts which led to early sensor removal.
 
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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 Key19169793
MDR Text Key341593900
Report Number3009862700-2024-00637
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 04/23/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/23/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number101967-950
Device Catalogue NumberFG-4500-50-302
Device Lot NumberWP09514
Was Device Available for Evaluation? No
Date Manufacturer Received03/25/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured05/30/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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