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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SENSEONICS INC. EVERSENSE TRANSMITTER; EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM
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SENSEONICS INC. EVERSENSE TRANSMITTER; EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM Back to Search Results
Model Number 102208-500
Device Problem Imprecision (1307)
Patient Problem Hypoglycemia (1912)
Event Date 11/20/2019
Event Type  Injury  
Manufacturer Narrative
The manufacturer is currently performing an investigation and will provide the results with the supplemental report.
 
Event Description
On nov 20th, 2019, senseonics was made aware of an incident where the user experienced a hypoglycemia event and the system did not alert the user.
 
Manufacturer Narrative
The user did not provide sufficient information and stopped communicating.Hence,no further information could be obtained and investigation was not possible.H6 result code updated to 3221.H6 conclusion code updated to 4315.
 
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Brand Name
EVERSENSE TRANSMITTER
Type of Device
EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM
Manufacturer (Section D)
SENSEONICS INC.
20451 seneca meadows parkway
germantown MD 20875 7005
MDR Report Key9504014
MDR Text Key177964400
Report Number3009862700-2019-00356
Device Sequence Number1
Product Code QCD
UDI-Device Identifier00817491021441
UDI-Public00817491021441
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 11/20/2019
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
Device Operator Lay User/Patient
Device Expiration Date12/17/2019
Device Model Number102208-500
Device Catalogue NumberFG-3300-01-001
Device Lot Number111495-C
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 11/20/2019
Initial Date FDA Received12/20/2019
Supplement Dates Manufacturer Received11/20/2019
Supplement Dates FDA Received03/05/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age38 YR
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