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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 Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)
Event Date 11/14/2019
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
The return material authorization (rma) was authorized but not received so no further confirmation or investigation of the complaint is possible.
 
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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 20875 7005
MDR Report Key9469421
MDR Text Key183681884
Report Number3009862700-2019-00326
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 11/14/2019
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 Date04/12/2020
Device Model Number102096-67A
Device Catalogue NumberFG-4200-00-301
Device Lot NumberWP06132
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 11/14/2019
Initial Date FDA Received12/13/2019
Supplement Dates Manufacturer Received11/14/2019
Supplement Dates FDA Received07/04/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age43 YR
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