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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 Failure to Sense (1559)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/13/2023
Event Type  malfunction  
Event Description
On november 14, 2023, senseonics was made aware of an incident where 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.
 
Manufacturer Narrative
The review of the glucose plot showed two consecutive drop out phases 14 days apart that triggered the sensor replacement alert on november 13, 2023.The returned sensor was tested in-house, and the failure mode could not be reproduced.This may occur in some instances where the failure mode that presents itself in the body is not reproduced in the lab.The potential root cause for such failure mode may be related to an issue with the sensor electronics, for example the led behavior at the time, or the in vivo state of the sensor hydrogel.As part of resolution, the rma was authorized for sensor replacement.B4.Date of this report updated to 21 march 2024.G3.Date received by manufacturer updated to 09 february 2024.H3.Device evaluated by manufacturer? yes.H6.Type of investigation updated to 10.H6.Investigation findings updated to 3231.H6.Investigation conclusions updated to 4307.
 
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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 Key18311846
MDR Text Key330292266
Report Number3009862700-2023-00820
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 03/21/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date12/28/2023
Device Model Number102096-81A
Device Catalogue NumberFG-7200-00-301
Device Lot NumberWP09137
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/21/2023
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 11/14/2023
Initial Date FDA Received12/12/2023
Supplement Dates Manufacturer Received02/09/2024
Supplement Dates FDA Received03/21/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/16/2023
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 Age53 YR
Patient SexMale
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