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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 01/06/2024
Event Type  Injury  
Manufacturer Narrative
This mdr is a result of retrospective review of complaints.According to the case notes, the area was palpable, and the transmitter was utilized to localize the area of the sensor but the sensor could not be removed.The next removal procedure is scheduled for (b)(6) 2024.
 
Event Description
On january 12, 2024, senseonics was made aware of an adverse event where the hcp could not remove the sensor from the user's arm on the first attempt.
 
Manufacturer Narrative
Sensor was successfully removed on (b)(6) 2024.No further investigation is required.B4.Date of this report 25 april 2024.D6b.Explanted date updated to (b)(6) 2024.G3.Date received by the manufacturer? 23 feb 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 Key18764446
MDR Text Key336050110
Report Number3009862700-2024-00070
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 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 Date12/22/2023
Device Model Number102096-81A
Device Catalogue NumberFG-7200-00-301
Device Lot NumberWP09237
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 01/12/2024
Initial Date FDA Received02/22/2024
Supplement Dates Manufacturer Received02/23/2024
Supplement Dates FDA Received04/25/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured02/07/2023
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 Outcome(s) Other;
Patient Age40 YR
Patient SexFemale
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