Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EVERSENSE TRANSMITTER; CONTINUOUS GLUCOSE MONITORING 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
 

EVERSENSE TRANSMITTER; CONTINUOUS GLUCOSE MONITORING SYSTEM Back to Search Results
Model Number 102208-500
Device Problems Device Alarm System (1012); Imprecision (1307)
Patient Problem Hyperglycemia (1905)
Event Date 08/08/2019
Event Type  Injury  
Manufacturer Narrative
The manufacturer is currently performing an investigation and will provide the results with the supplemental report.
 
Event Description
On (b)(6) 2019 senseonics was made aware of an adverse event where the user experienced a hyperglycemia event and reported the continuous glucose monitoring system did not alert her.The user did not require medical attention.
 
Manufacturer Narrative
The sensor glucose readings appeared to have a high rate of variation as compared to observations in the clinical trial, due to potential noise in the system.Sensor replacement was recommended for the user.G1-2 contact information was updated, h6 device code was updated to 1307, h6 results code was updated to 114, h6 conclusions code was updated to 4315.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
EVERSENSE TRANSMITTER
Type of Device
CONTINUOUS GLUCOSE MONITORING SYSTEM
MDR Report Key8972630
MDR Text Key156942663
Report Number3009862700-2019-00078
Device Sequence Number1
Product Code QCD
UDI-Device Identifier00817491021441
UDI-Public00817491021441
Combination Product (y/n)N
PMA/PMN Number
P160048
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial,Followup
Report Date 08/08/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/06/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date04/03/2020
Device Model Number102208-500
Device Catalogue NumberFG-3300-01-001
Device Lot Number113024
Was Device Available for Evaluation? No
Date Manufacturer Received08/08/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age37 YR
-
-