• 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 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
 

SENSEONICS INC. EVERSENSE SENSOR; EVERSENSE CONTINUOUS GLUCOSE MONITORING SYSTEM Back to Search Results
Model Number 102096-67A
Device Problem No Apparent Adverse Event (3189)
Patient Problem No Code Available (3191)
Event Date 12/03/2019
Event Type  malfunction  
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 a situation where a device is to be removed early due to customer satisfaction (sensor check alerts).
 
Manufacturer Narrative
The customer complaint was confirmed after looking at in-vivo data in dms.The in-vitro qc tests is inconclusive since hydrogel was found to be missing over the portion of sensor optics.Result code updated to 3221.Conclusion code updated to 4315.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
EVERSENSE SENSOR
Type of Device
EVERSENSE CONTINUOUS GLUCOSE MONITORING SYSTEM
Manufacturer (Section D)
SENSEONICS INC.
20451 seneca meadows parkway
germantown MD 20875 7005
MDR Report Key9540007
MDR Text Key183547024
Report Number3009862700-2020-00012
Device Sequence Number1
Product Code QCD
UDI-Device Identifier00817491022349
UDI-Public00817491022349
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 12/03/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/02/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date06/14/2020
Device Model Number102096-67A
Device Catalogue NumberFG-4200-00-301
Device Lot NumberWP06795
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/31/2020
Date Manufacturer Received12/03/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age60 YR
-
-