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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SENSEONICS INC EVERSENSE SENSOR; EVERSENSE CONTINUOUS GLUCOSE MONITORING SYSTEM
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SENSEONICS INC EVERSENSE SENSOR; EVERSENSE CONTINUOUS GLUCOSE MONITORING SYSTEM Back to Search Results
Model Number 102096-67A
Device Problem Failure to Sense (1559)
Patient Problem No Information (3190)
Event Date 11/17/2019
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, the sensor experienced an early sensor retirement thereby requiring early removal of the inserted device.
 
Manufacturer Narrative
This sensor (small led sensor and mep spike issue) is part of the issue being addressed by corrective and preventive action.No further investigation is necessary on this rma since the capa resolution will apply to this case.H6 result code updated to 706.H6 conclusion code updated to 23.
 
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Brand Name
EVERSENSE SENSOR
Type of Device
EVERSENSE CONTINUOUS GLUCOSE MONITORING SYSTEM
Manufacturer (Section D)
SENSEONICS INC
20451 seneca meadows parkway
germantown MD 20876 7005
MDR Report Key9478533
MDR Text Key183568464
Report Number3009862700-2019-00298
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 11/17/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date05/16/2020
Device Model Number102096-67A
Device Catalogue NumberFG-4200-00-301
Device Lot NumberWP06329
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/03/2019
Initial Date Manufacturer Received 11/17/2019
Initial Date FDA Received12/17/2019
Supplement Dates Manufacturer Received11/17/2019
Supplement Dates FDA Received04/07/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age62 YR
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