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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SENSEONICS INCORPORATED EVERSENSE TRANSMITTER; CONTINUOUS GLUCOSE MONITOR
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SENSEONICS INCORPORATED EVERSENSE TRANSMITTER; CONTINUOUS GLUCOSE MONITOR Back to Search Results
Model Number 102208-500
Device Problems Imprecision (1307); Inaccurate Information (4051)
Patient Problem Hypoglycemia (1912)
Event Date 06/18/2019
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)(4) 2019 senseonics was made aware of an adverse event where the user experienced a hypoglycemia event and was assisted by the emt that was called by a bystander.The user did not require hospitalization.
 
Manufacturer Narrative
Based on the investigation results there was no malfunction observed with the eversense continuous glucose monitoring (cgm) system.
 
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Brand Name
EVERSENSE TRANSMITTER
Type of Device
CONTINUOUS GLUCOSE MONITOR
Manufacturer (Section D)
SENSEONICS INCORPORATED
20451 seneca meadows parkway
germantown MD 20876 7005
MDR Report Key8798239
MDR Text Key151297274
Report Number3009862700-2019-00037
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 06/18/2019
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 Date05/15/2019
Device Model Number102208-500
Device Catalogue NumberFG-3300-01-001
Device Lot Number107537
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 06/18/2019
Initial Date FDA Received07/17/2019
Supplement Dates Manufacturer Received06/18/2019
Supplement Dates FDA Received05/28/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age50 YR
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