• 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 101967-950
Device Problem Material Separation (1562)
Patient Problem Pain (1994)
Event Date 11/20/2023
Event Type  Injury  
Manufacturer Narrative
The manufacturer is currently performing evaluation and the results will be provided in a supplemental report.
 
Event Description
Senseonics was made aware of an incident where the sensor broke during removal procedure.The transparent end piece of the sensor became came loose during removal, while trying to grab the sensor with the clamp.The hcp, however, was able to completely remove the sensor.
 
Manufacturer Narrative
Per case notes, the sensor was broken during removal into two pieces and the endcap was separated from the sensor.The hcp was able to remove both the pieces.The rma was authorized for the removed sensor but not received.The root cause for sensor fracture is usually excessive force applied by the removal clamps or grabbing an extremity of the sensor.In some cases, the patient's tissue at insertion sites may encapsulate the sensor, obstructing its removal.The doctor may then attempt excessive force on the clamps and risk fracturing the sensor.The hcp was able to remove all fragments of the broken sensor.No further resolution was found necessary.B4: date of this report updated to 29 january 2024.G3: date received by manufacturer updated to 04 january 2024.H3: device evaluated by manufacturer? not returned to manufacturer.H6: investigation findings updated to 3221.H6: investigation conclusions updated to 4311.
 
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 20876 7005
Manufacturer (Section G)
SENSEONICS INC.
20451 seneca meadows parkway
germantown MD 20876 7005
Manufacturer Contact
vallikannu somasundaram
20451 seneca meadows parkway
germantown, MD 20876-7005
MDR Report Key18314270
MDR Text Key330326021
Report Number3009862700-2023-00828
Device Sequence Number1
Product Code QHJ
Combination Product (y/n)Y
Reporter Country CodeGM
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,Followup
Report Date 01/29/2024
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 Date06/30/2023
Device Model Number101967-950
Device Catalogue NumberFG-4500-50-302
Device Lot NumberWP09004
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 11/21/2023
Initial Date FDA Received12/12/2023
Supplement Dates Manufacturer Received01/04/2024
Supplement Dates FDA Received01/29/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/05/2022
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;
-
-