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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 102812-81A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Itching Sensation (1943); Discomfort (2330)
Event Date 04/14/2023
Event Type  Injury  
Manufacturer Narrative
Development of infection at the sensor insertion site is a known and anticipated potential adverse effect.The sensor is inserted by making a small incision and placing it under skin, and potential for developing skin irritation/inflammation/infection at the insertion site is a known anticipated adverse event.The user was prescribed with antibiotics by hcp to treat the infection at insertion site.The user confirms that the infection is now gone.A review of the device's manufacturing records revealed that the sensor lot met all requirements including sterilization requirements for release.No further investigation is required.
 
Event Description
On (b)(6) 2023, senseonics was made aware of an adverse event where the user reports of infection on multiple occasions at the insertion site.The user also reports of seeing blood, redness and itching at insertion site.
 
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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 20875 7005
Manufacturer (Section G)
SENSEONICS INC.
20451 seneca meadows parkway
germantown MD 20875 7005
Manufacturer Contact
vallikannu somasundaram
20451 seneca meadows parkway
germantown, MD 20875-7005
MDR Report Key17343813
MDR Text Key319281300
Report Number3009862700-2023-00121
Device Sequence Number1
Product Code QHJ
UDI-Device Identifier00817491022974
UDI-Public817491022974
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 04/15/2023
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 Date11/03/2023
Device Model Number102812-81A
Device Catalogue NumberFG-7202-00-301
Device Lot NumberWP09134
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 04/15/2023
Initial Date FDA Received07/18/2023
Was Device Evaluated by Manufacturer? No
Date Device Manufactured11/15/2022
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 Age68 YR
Patient SexMale
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