• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SENSEONICS INC. EVERSENSE SENSOR; EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

SENSEONICS INC. EVERSENSE SENSOR; EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM Back to Search Results
Model Number 102096-67A
Device Problems Off-Label Use (1494); Difficult to Remove (1528)
Patient Problem Discomfort (2330)
Event Date 11/19/2019
Event Type  Injury  
Manufacturer Narrative
This mdr is result of a retrospective review of complaints.There will be no further attempts to remove sensor from the patient.The sensor can stay inside user's body as it is biocompatible in nature.User is doing well.
 
Event Description
On (b)(6) 2019, senseonics was made aware of an incident where the physician was unable to explant the eversense sensor on the first attempt made on (b)(6) 2019.Senseonics was made aware on (b)(6) 2019, of a second attempt made on (b)(6) 2019, to remove the same eversense sensor where the physician was unable to explant the device.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key10022076
MDR Text Key189778455
Report Number3009862700-2020-00304
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 company representative
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? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date04/12/2020
Device Model Number102096-67A
Device Catalogue NumberFG-4200-00-301
Device Lot NumberWP06132
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 11/19/2019
Initial Date FDA Received05/04/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/11/2019
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 Age44 YR
-
-