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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 Material Separation (1562)
Patient Problem Discomfort (2330)
Event Date 06/05/2023
Event Type  Injury  
Event Description
On 13 june 2023,senseonics was made aware of an adverse event where sensor broke during removal procedure.First hcp believed that all pieces of had been removed during the procedure.Second hcp performed an ultrasound and stated no other pieces could be located and confirmed that they were removed on the initial attempt.
 
Manufacturer Narrative
The sensor broke during the removal procedure.First hcp believed that all pieces had been removed during procedure.Second hcp performed an ultrasound and stated no other pieces could be located and confirmed that they were removed on the initial attempt.No further investigation is required.
 
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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 Key17330872
MDR Text Key319094017
Report Number3009862700-2023-00150
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
Report Date 06/13/2023
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 Date03/28/2023
Device Model Number102096-81A
Device Catalogue NumberFG-7200-00-301
Device Lot NumberWP08822
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 06/13/2023
Initial Date FDA Received07/16/2023
Was Device Evaluated by Manufacturer? No
Date Device Manufactured05/24/2022
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 Age54 YR
Patient SexFemale
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