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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 101967-950
Device Problem Difficult to Remove (1528)
Patient Problem Discomfort (2330)
Event Date 12/06/2023
Event Type  Injury  
Manufacturer Narrative
The manufacturer is currently waiting for additional information regarding next sensor removal attempt.The additional information will be provided in the supplemental report.
 
Event Description
On december 27, 2023, senseonics was made aware of an incident where the previous sensor could not be removed during removal procedure on (b)(6) 2023.The next removal attempt will be done after (b)(6).
 
Manufacturer Narrative
The sensor was successfully removed and was inserted with a new sensor on (b)(6) 2024.Date of this report 10 june 2024 primary unique device identifier (udi) number updated to(b)(4).Explanted date updated to (b)(6) 2024.Date received by the manufacturer? 06 june 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 Key18592530
MDR Text Key333894037
Report Number3009862700-2024-00007
Device Sequence Number1
Product Code QHJ
UDI-Device Identifier00817491023308
UDI-Public817491023308
Combination Product (y/n)Y
Reporter Country CodeIT
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 06/10/2024
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 Date10/12/2023
Device Model Number101967-950
Device Catalogue NumberFG-4500-50-302
Device Lot NumberWP09042
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 12/27/2023
Initial Date FDA Received01/26/2024
Supplement Dates Manufacturer Received06/06/2024
Supplement Dates FDA Received06/10/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured10/26/2022
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;
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