• 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 101967-750
Device Problem Imprecision (1307)
Patient Problems Headache (1880); Hypoglycemia (1912)
Event Date 10/02/2022
Event Type  Injury  
Manufacturer Narrative
This report is being submitted retrospectively as part of an internal review.Transmitter was the initial suspected device.However, preliminary investigation analysis revealed a deviation (from the normal behavior) in the sensor performance.The preliminary investigation was performed on the user's in vivo sensor data synced by the user on the data management system (dms), which is the data cloud platform for eversense systems.To further analyze the performance deviation and to determine the root cause of the malfunction, a return material authorization (rma) was authorized to bring back the sensor.But since the device was never returned.Hence no root cause analysis was possible.
 
Event Description
On october 12, 2022, senseonics was made aware of a hypoglycemia incident where patient complained of inaccurate sensor readings.Patient didn't provide a blood glucose reading but mentioned that the sensor glucose reading was 91 mg/dl.Patient did not receive a low glucose alert and was symptomatic.Patient had symptoms such as headache and blurry vision.Patient self treated with water and sugar.
 
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 Key19009470
MDR Text Key338980572
Report Number3009862700-2024-00372
Device Sequence Number1
Product Code QCD
UDI-Device Identifier00817491023360
UDI-Public817491023360
Combination Product (y/n)Y
Reporter Country CodeIT
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 03/31/2024
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 Date07/14/2022
Device Model Number101967-750
Device Catalogue NumberFG-4400-50-302
Device Lot NumberWP08492
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 11/23/2022
Initial Date FDA Received03/31/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/14/2021
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;
-
-