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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SENSEONICS INC EVERSENSE TRANSMITTER; CONTINUOUS GLUCOSE MONITORING SYSTEM
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SENSEONICS INC EVERSENSE TRANSMITTER; CONTINUOUS GLUCOSE MONITORING SYSTEM Back to Search Results
Model Number 102208-500
Device Problem Intermittent Communication Failure (4038)
Patient Problem Hypoglycemia (1912)
Event Date 08/02/2019
Event Type  Injury  
Manufacturer Narrative
The manufacturer is currently performing an investigation and will provide the results with the supplemental report.
 
Event Description
On (b)(6) 2019 senseonics was made aware of an instance where a user had a hypoglycemia event and at the time of occurence the transmitter was disconnected.
 
Manufacturer Narrative
The transmitter was disconnected at the time of the hypo event, however, the user did mention receiving a predictive low glucose alert prior to the disconnect.The system worked as designed, no malfunction was detected.
 
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Brand Name
EVERSENSE TRANSMITTER
Type of Device
CONTINUOUS GLUCOSE MONITORING SYSTEM
Manufacturer (Section D)
SENSEONICS INC
20451 seneca meadows parkway
germantown MD 20876 7005
MDR Report Key8952493
MDR Text Key156943544
Report Number3009862700-2019-00077
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 company representative
Type of Report Initial,Followup
Report Date 08/02/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/30/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date04/03/2019
Device Model Number102208-500
Device Catalogue NumberFG-3300-01-001
Device Lot Number113023
Was Device Available for Evaluation? No
Date Manufacturer Received08/02/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age22 YR
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