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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EVERSENSE TRANSMITTER; EVERSENSE CONTINUOUS GLUCOSE MONITORING SYSTEM
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EVERSENSE TRANSMITTER; EVERSENSE CONTINUOUS GLUCOSE MONITORING SYSTEM Back to Search Results
Model Number 102208-500
Device Problem Imprecision (1307)
Patient Problem Hypoglycemia (1912)
Event Date 11/19/2019
Event Type  Injury  
Manufacturer Narrative
The manufacturer is performing an investigation and will provide the results in a supplement.
 
Event Description
On november 20th, 2019, senseonics was made aware of an incident where the user experienced a hypoglycemia event and the system did not alert.
 
Manufacturer Narrative
Based on the investigation, it was observed, there was malfunction in the sensor performance which lead to sensor inaccuracies.It was suggested to replace the sensor and issue a new sensor to the user.Once the new sensor was inserted, the user did not have any further complains about sensor inaccuracy.
 
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Brand Name
EVERSENSE TRANSMITTER
Type of Device
EVERSENSE CONTINUOUS GLUCOSE MONITORING SYSTEM
MDR Report Key9507785
MDR Text Key172424134
Report Number3009862700-2019-00354
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 Date12/01/2019
Device Model Number102208-500
Device Catalogue NumberFG-3300-01-001
Device Lot Number111037
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 11/19/2019
Initial Date FDA Received12/20/2019
Supplement Dates Manufacturer Received11/19/2019
Supplement Dates FDA Received03/24/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age56 YR
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