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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 01/04/2023
Event Type  Injury  
Manufacturer Narrative
This mdr is a result of retrospective review of complaints.Despite multiple follow up attempts with the user the removal status of the sensor could not be confirmed.No further investigation is required.
 
Event Description
On (b)(6) 2023, senseonics was made aware of an adverse event where the user reported a failed removal attempt.
 
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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 20876 7005
Manufacturer Contact
vallikannu somasundaram
20451 seneca meadows parkway
germantown 20876-7005
MDR Report Key18252900
MDR Text Key329551295
Report Number3009862700-2023-00220
Device Sequence Number1
Product Code QHJ
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
Report Date 12/01/2023
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 Date12/30/2022
Device Model Number102096-81A
Device Catalogue NumberFG-7200-00-301
Device Lot NumberWP08799
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 10/24/2023
Initial Date FDA Received12/01/2023
Was Device Evaluated by Manufacturer? No
Date Device Manufactured01/26/2022
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 Age61 YR
Patient SexFemale
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