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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SENSEONICS INC EVERSENSE SENSOR; CONTINUOUS GLUCOSE MONITOR
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SENSEONICS INC EVERSENSE SENSOR; CONTINUOUS GLUCOSE MONITOR Back to Search Results
Model Number 102620-67A
Medical Device Problem Code Difficult to Remove (1528)
Health Effect - Clinical Code Discomfort (2330)
Date of Event 08/23/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The manufacturer is currently performing an investigation and will provide the results with the supplemental report.
 
Event or Problem Description
On (b)(6) 2019, senseonics was made aware of an incident where a physician was unable to explant the eversense sensor.
 
Additional Manufacturer Narrative
The eversense sensor was successfully removed during the second removal attempt on (b)(6) 2019.
 
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Brand Name
EVERSENSE SENSOR
Common Device Name
CONTINUOUS GLUCOSE MONITOR
Manufacturer (Section D)
SENSEONICS INC
20451 seneca meadows parkway
germantown MD 20876 7005
MDR Report Key9084268
Report Number3009862700-2019-00116
Device Sequence Number16799917
Product Code QCD
UDI-Device Identifier00817491021427
UDI-Public00817491021427
Combination Product (Y/N)N
Initial Reporter StateMD
Initial Reporter CountryUS
PMA/510(K) Number
P160048
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date (Section B) 08/23/2019
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
Operator of Device Lay User/Patient
Device Expiration Date06/07/2019
Device Model Number102620-67A
Device Catalogue NumberFG-4201-00-301
Device Lot NumberWP04530
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 08/23/2019
Supplement Date Received by Manufacturer08/23/2019
Initial Report FDA Received Date09/18/2019
Supplement Report FDA Received Date10/11/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
Patient Age22 YR
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