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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SENSEONICS INC EVERSENSE TRANSMITTER; CONTINUOUS GLUCOSE MONITOR SYSTEM
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SENSEONICS INC EVERSENSE TRANSMITTER; CONTINUOUS GLUCOSE MONITOR SYSTEM Back to Search Results
Model Number 81864
Device Problems Device Alarm System (1012); Imprecision (1307)
Patient Problem Hypoglycemia (1912)
Event Date 07/28/2019
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 hypoglycemia event and reported the continuous glucose monitoring system had an inaccurate reading and as a result did not alert her.The user did not require medical attention.
 
Manufacturer Narrative
Based on the investigation there was no malfunction observed with the eversense continuous glucose monitoring (cgm) system.Device code was updated to 1307.Results code was updated to 213.Conclusions code was updated to 67.
 
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Brand Name
EVERSENSE TRANSMITTER
Type of Device
CONTINUOUS GLUCOSE MONITOR SYSTEM
Manufacturer (Section D)
SENSEONICS INC
20451 seneca meadows parkway
germantown MD 20876 7005
MDR Report Key8942077
MDR Text Key160511379
Report Number3009862700-2019-00072
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 07/29/2019
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 No Information
Device Expiration Date11/12/2019
Device Model Number81864
Device Catalogue NumberFG-3300-01-001
Device Lot Number81864
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 07/29/2019
Initial Date FDA Received08/28/2019
Supplement Dates Manufacturer Received07/29/2019
Supplement Dates FDA Received06/01/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age61 YR
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