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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 102096-67A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Unspecified Infection (1930)
Event Date 08/26/2020
Event Type  Injury  
Manufacturer Narrative
Development of infection at the sensor insertion site is a known and anticipated potential adverse effect.User was prescribed with antibiotics to treat the infection and is getting better.
 
Event Description
On august 30th 2020, senseonics was made aware of an adverse event where user had an infection on the insertion site.User arm was red, swollen and pus was oozing out of the site.User was prescribed with antibiotics for the infection.
 
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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 Key10587498
MDR Text Key208567259
Report Number3009862700-2020-00499
Device Sequence Number1
Product Code QCD
UDI-Device Identifier00817491022349
UDI-Public00817491022349
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 08/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/25/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date09/27/2020
Device Model Number102096-67A
Device Catalogue NumberFG-4200-00-301
Device Lot NumberWP07483
Was Device Available for Evaluation? No
Date Manufacturer Received08/30/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/07/2019
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 Age36 YR
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