EVERSENSE SENSOR 102096-67A FG-4200-00-301

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-30 for EVERSENSE SENSOR 102096-67A FG-4200-00-301 manufactured by Senseonics Inc..

Event Text Entries

[185975895] The manufacturer is currently performing an investigation and will provide the results with the supplemental report.
Patient Sequence No: 1, Text Type: N, H10


[185975896] On (b)(6) 2020,senseonics was made aware of an incident where user experienced an early sensor replacement alert resulting in an early sensor removal.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3009862700-2020-00391
MDR Report Key9900430
Report SourceCOMPANY REPRESENTATIVE
Date Received2020-03-30
Date of Report2020-02-29
Date of Event2020-02-28
Date Mfgr Received2020-02-29
Device Manufacturer Date2019-08-21
Date Added to Maude2020-03-30
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 SENSOR
Generic NameEVERSENSE CONTINUOUS GLUCOSE MONITORING SYSTEM
Product CodeQCD
Date Received2020-03-30
Model Number102096-67A
Catalog NumberFG-4200-00-301
Lot NumberWP07053
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerSENSEONICS INC.
Manufacturer Address20451 SENECA MEADOWS PARKWAY GERMANTOWN,, MD US


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-30

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