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: SENSEONICS INCORPORATED EVERSENSE TRANSMITTER; CONTINUOUS GLUCOSE MONITOR
  • 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 INCORPORATED EVERSENSE TRANSMITTER; CONTINUOUS GLUCOSE MONITOR Back to Search Results
Model Number 102095-67A
Device Problems Device Alarm System (1012); Imprecision (1307)
Patient Problem Hypoglycemia (1912)
Event Date 06/25/2019
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 hypoglycemia event.The user reported that at night he turns the volume/sound off on his phone because he feels the alerts at night disturb his sleep.The user was able to self-treat and did not require any medical attention.
 
Manufacturer Narrative
The user received sensor replacement alert later on the same day.Based on the investigation there was a malfunction observed with the sensor and the algorithm accurately triggered the early sensor retirement alert for the sensor.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
EVERSENSE TRANSMITTER
Type of Device
CONTINUOUS GLUCOSE MONITOR
Manufacturer (Section D)
SENSEONICS INCORPORATED
20451 seneca meadows parkway
germantown MD 20876 7005
MDR Report Key8829240
MDR Text Key152470629
Report Number3009862700-2019-00046
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 company representative
Type of Report Initial,Followup
Report Date 06/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/25/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date01/17/2020
Device Model Number102095-67A
Device Catalogue NumberFG-3300-01-001
Device Lot NumberWP05751
Was Device Available for Evaluation? No
Date Manufacturer Received06/25/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age56 YR
-
-