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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 12/19/2023
Event Type  Injury  
Event Description
On december 19, 2023, senseonics was made aware of an adverse event where a sensor broke during the removal procedure.
 
Manufacturer Narrative
When the hcp first pulled the sensor out with the clamp, only the bottom part with the ring was removed.When the hcp went back in to remove the other piece, some dark tissue was removed before removing the rest of the sensor.The sensor was removed in its entirety.The manufacturer is currently performing an investigation and will provide the results with the supplemental report.
 
Manufacturer Narrative
Sensor was received, a visual inspection showed that the end cap was separated from the sensor.All sensor pieces were successfully removed from the patient.The root cause for sensor breakage is usually excessive force on the removal clamps or grabbing an extremity of the sensor.B4.Date of this report 01 march 2024.G3.Date received by the manufacturer? 01 feb 2024.H3.Device evaluated by manufacturer?yes.
 
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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 Key18531968
MDR Text Key333087138
Report Number3009862700-2024-00055
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 Health Professional
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 03/01/2024
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 Date03/28/2023
Device Model Number102096-81A
Device Catalogue NumberFG-7200-00-301
Device Lot NumberWP08822
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/26/2023
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 12/19/2023
Initial Date FDA Received01/17/2024
Supplement Dates Manufacturer Received02/01/2024
Supplement Dates FDA Received03/01/2024
Was Device Evaluated by Manufacturer? Yes
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 Outcome(s) Other;
Patient Age65 YR
Patient SexFemale
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