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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 101368-67A
Device Problems Device Appears to Trigger Rejection (1524); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Swelling/ Edema (4577)
Event Date 01/06/2019
Event Type  Injury  
Manufacturer Narrative
This report is being submitted retrospectively as part of an internal review.The risks identified for the eversense¿ cgm system are common to all cgm systems even though a minor surgical procedure is required for insertion and removal of the sensor.These include local infection, pain or discomfort, inflammation, bleeding at the insertion or removal site, bruising, itching, scarring or skin discoloration, hematoma, erythema, adhesive tape irritation and sensor fracture.There is no remedial action/corrective action/preventive action/field safety corrective action required in this case as the device is not defective.The potential develop pain at the insertion site is a known and anticipated adverse effect of the system.The patient visited the healthcare facility and they decided to remove the sensor on his request.
 
Event Description
Senseonics was recently made aware of an incident where the patient reported pain and swelling at the insertion site since the insertion of the eversense sensor.The patient went to the hospital to obtain painkillers to reduce the pain and swelling, however, the pain and swelling did not subside.As a result, the sensor was removed from the patient.
 
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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 20876-7005
MDR Report Key18271385
MDR Text Key329775900
Report Number3009862700-2023-00340
Device Sequence Number1
Product Code QCD
Combination Product (y/n)Y
Reporter Country CodeSZ
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 12/05/2023
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 Date05/25/2019
Device Model Number101368-67A
Device Catalogue NumberFG-4400-XX-302
Device Lot NumberWP04393
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 02/11/2019
Initial Date FDA Received12/05/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/23/2018
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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