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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SENSEONICS INC. EVERSENSE SENSOR; CONTINUOUS GLUCOSE MONITORING SYSTEM
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SENSEONICS INC. EVERSENSE SENSOR; CONTINUOUS GLUCOSE MONITORING SYSTEM Back to Search Results
Model Number 102096-67A
Medical Device Problem Code Communication or Transmission Problem (2896)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 08/27/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
This mdr is result of a retrospective review of complaints.The sensor was replaced and returned for analysis.The malfunction was confirmed.
 
Event or Problem Description
On (b)(6) 2018, senseonics was made aware of a situation where user experienced constant disconnections between transmitter and sensor.
 
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Brand Name
EVERSENSE SENSOR
Common Device Name
CONTINUOUS GLUCOSE MONITORING SYSTEM
Manufacturer (Section D)
SENSEONICS INC.
20451 seneca meadows parkway
germantown, md
MDR Report Key9944235
Report Number3009862700-2020-00228
Device Sequence Number3257379
Product Code QCD
UDI-Device Identifier00817491021410
UDI-Public00817491021410
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
P160048
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Reporter Type Manufacturer
Report Source consumer
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 08/27/2018
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 No Information
Device Expiration Date12/08/2018
Device Model Number102096-67A
Device Catalogue NumberFG-4200-00-301
Device Lot NumberWP04043
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/21/2018
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/27/2018
Initial Report FDA Received Date04/09/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Patient Age71 YR
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