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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SENSEONICS INC EVERSENSE TRANSMITTER; EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM
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SENSEONICS INC EVERSENSE TRANSMITTER; EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM Back to Search Results
Model Number 102208-510
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Hypoglycemia (1912)
Date of Event 09/11/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Device can not be investigated further as it is in use by patient.Manufacturer narrative: no malfunction was detected with the device.
 
Event or Problem Description
On (b)(6) 2019, senseonics was made aware of an incident where the user experienced a hypoglycemic event and the cgm system did not alert her.
 
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Brand Name
EVERSENSE TRANSMITTER
Common Device Name
EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM
Manufacturer (Section D)
SENSEONICS INC
20451 seneca meadows parkway
germantown MD 20876 7005
MDR Report Key9211130
Report Number3009862700-2019-00157
Device Sequence Number14239576
Product Code QCD
UDI-Device Identifier00817491021458
UDI-Public00817491021458
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
P160048
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source consumer
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 09/13/2019
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
Operator of Device Lay User/Patient
Device Expiration Date11/05/2019
Device Model Number102208-510
Device Catalogue NumberFG-3301-01-001
Device Lot Number110552
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/13/2019
Initial Report FDA Received Date10/18/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
Patient Age55 YR
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