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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SENSEONICS INC. EVERSENSE SENSOR; EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM
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SENSEONICS INC. EVERSENSE SENSOR; EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM Back to Search Results
Device Problem Connection Problem (2900)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/06/2019
Event Type  malfunction  
Manufacturer Narrative
This mdr is result of a retrospective review of complaints.The rma was authorized but not received so no further confirmation or investigation of the complaint is possible.
 
Event Description
On (b)(6) 2019,senseonics was made aware of an incident where user reports that with multiple transmitters they have not been able to link the sensor as the placement guide shows no signal resulting in sensor removal.
 
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Brand Name
EVERSENSE SENSOR
Type of Device
EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM
Manufacturer (Section D)
SENSEONICS INC.
20451 seneca meadows parkway
germantown, md
Manufacturer (Section G)
SENSEONICS INC.
20451 seneca meadows parkway
germantown, md
Manufacturer Contact
vallikannu somasundaram
20451 seneca meadows parkway
germantown, md 
MDR Report Key10008152
MDR Text Key189308973
Report Number3009862700-2020-00280
Device Sequence Number1
Product Code QCD
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P160048
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Other
Type of Report Initial
Report Date 11/18/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/28/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Was Device Available for Evaluation? No
Date Manufacturer Received11/18/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/18/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age22 YR
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