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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SENSEONICS INC EVERSENSE TRANSMITTER; CONTINUOUS GLUCOSE MONITOR
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SENSEONICS INC EVERSENSE TRANSMITTER; CONTINUOUS GLUCOSE MONITOR Back to Search Results
Model Number 102208-500
Device Problem Low Audible Alarm (1016)
Patient Problem Hyperglycemia (1905)
Event Date 07/07/2019
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 adverse event where the user experienced a hyperglycemia event and was hospitalized.
 
Manufacturer Narrative
Based on the investigation there was no malfunction observed with the eversense cgm system.The user's glucose value was above the range that can be calculated by the eversense cgm system and the user was provided the out of range alert.
 
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Brand Name
EVERSENSE TRANSMITTER
Type of Device
CONTINUOUS GLUCOSE MONITOR
Manufacturer (Section D)
SENSEONICS INC
20451 seneca meadows parkway
germantown MD 20876 7005
MDR Report Key8880958
MDR Text Key153960584
Report Number3009862700-2019-00062
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 07/12/2019
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 Date12/14/2019
Device Model Number102208-500
Device Catalogue NumberFG-3300-01-001
Device Lot Number111449-C
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 07/12/2019
Initial Date FDA Received08/09/2019
Supplement Dates Manufacturer Received07/12/2019
Supplement Dates FDA Received11/13/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Other;
Patient Age18 YR
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