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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 Connection Problem (2900)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/19/2019
Event Type  malfunction  
Manufacturer Narrative
This mdr is result of a retrospective review of complaints.After an ultrasound was performed, it was discovered that there was no sensor present in the user's arm to begin with.It was later concluded that, this mishap occurred during the sensor installation phase where a sensor was falsely assumed embedded using the insertion tool.No rma for investigation necessary.
 
Event Description
On (b)(6) 2019,senseonics was made aware of an incident where user requested assistance in finishing up setting her eversense journey with specialist.Attempted to link sensor with transmitter but after multiple attempts was not able to.Ran troubleshooting during 20 minutes to determine the connection with the sensor but was not able to an ultra-sound was performed which revealed that no sensor was placed in 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
Manufacturer (Section G)
SENSEONICS INC.
20451 seneca meadows parkway
germantown, md
Manufacturer Contact
vallikannu somasundaram
20451 seneca meadows parkway
germantown, md 
MDR Report Key10008176
MDR Text Key189309413
Report Number3009862700-2020-00281
Device Sequence Number1
Product Code QCD
UDI-Device Identifier00817491022349
UDI-Public00817491022349
Combination Product (y/n)N
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 11/19/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date04/05/2020
Device Model Number102096-67A
Device Catalogue NumberFG-4200-00-301
Device Lot NumberWP06863
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 11/19/2019
Initial Date FDA Received04/28/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/04/2019
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 Age39 YR
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