EVERSENSE TRANSMITTER 102208-500 FG-3300-01-001

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-03-25 for EVERSENSE TRANSMITTER 102208-500 FG-3300-01-001 manufactured by Senseonics Inc..

Event Text Entries

[185225915] The manufacturer is currently performing an investigation and will provide the results with the supplemental report.
Patient Sequence No: 1, Text Type: N, H10


[185225916] On (b)(6) 2020,senseonics was made aware of an adverse event where the user experienced hyperglycemia.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3009862700-2020-00277
MDR Report Key9878461
Report SourceCONSUMER
Date Received2020-03-25
Date of Report2020-02-24
Date of Event2020-02-21
Date Mfgr Received2020-02-24
Device Manufacturer Date2018-11-12
Date Added to Maude2020-03-25
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. VALLIKANNU SOMASUNDARAM
Manufacturer Street20451 SENECA MEADOWS PARKWAY
Manufacturer CityGERMANTOWN, MD
Manufacturer CountryUS
Manufacturer G1SENSEONICS INC.
Manufacturer Street20451 SENECA MEADOWS PARKWAY
Manufacturer CityGERMANTOWN,, MD
Manufacturer CountryUS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameEVERSENSE TRANSMITTER
Generic NameEVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM
Product CodeQCD
Date Received2020-03-25
Model Number102208-500
Catalog NumberFG-3300-01-001
Lot Number110665
Device Expiration Date2019-11-12
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerSENSEONICS INC.
Manufacturer Address20451 SENECA MEADOWS PARKWAY GERMANTOWN,, MD US


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-25

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