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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 102620-67A
Medical Device Problem Code Difficult to Remove (1528)
Health Effect - Clinical Code Discomfort (2330)
Date of Event 02/28/2020
Type of Reportable Event Serious Injury
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) 2020, senseonics was made aware of an adverse event where the physician was unable to remove the sensor on the first attempt made.
 
Additional Manufacturer Narrative
No response was received after multiple attempts; thus status of sensor removal could not be confirmed.
 
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Brand Name
EVERSENSE SENSOR
Common Device Name
EVERSENSE CONTINUOUS GLUCOSE MONITORING SYSTEM
Manufacturer (Section D)
SENSEONICS INC.
20451 seneca meadows parkway
germantown,, md
MDR Report Key9911355
Report Number3009862700-2020-00393
Device Sequence Number16926932
Product Code QCD
UDI-Device Identifier00817491022356
UDI-Public00817491022356
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
P160048
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 03/02/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Lay User/Patient
Device Expiration Date04/06/2020
Device Model Number102620-67A
Device Catalogue NumberFG-4201-00-301
Device Lot NumberWP06869
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 03/02/2020
Supplement Date Received by Manufacturer03/02/2020
Initial Report FDA Received Date04/01/2020
Supplement Report FDA Received Date12/18/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Patient Age36 YR
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