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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 102620-81A
Device Problem Difficult to Remove (1528)
Patient Problem Discomfort (2330)
Event Date 12/29/2023
Event Type  Injury  
Manufacturer Narrative
Per case notes, the sensor was not palpable before the incision and the transmitter nor was an ultrasound used to localize the sensor.The user confirmed that a second removal attempt took place on (b)(6) 2024 and the sensor was successfully removed.
 
Event Description
On january 3, 2024, senseonics was made aware of an adverse event where the user experienced a failed removal attempt on (b)(6) 2023 due to the hcp not being able to locate the sensor in the user's arm.
 
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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 Key18628660
MDR Text Key334368350
Report Number3009862700-2024-00071
Device Sequence Number1
Product Code QHJ
UDI-Device Identifier00817491022967
UDI-Public817491022967
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 02/01/2024
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 Date08/04/2023
Device Model Number102620-81A
Device Catalogue NumberFG-7201-00-301
Device Lot NumberWP09023
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 01/03/2024
Initial Date FDA Received02/01/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured09/06/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age38 YR
Patient SexMale
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