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 consumer report with the FDA on 2020-03-13 for EVERSENSE SENSOR 102096-67A FG-4200-00-301 manufactured by Senseonics Inc..

Event Text Entries

[183567004] This mdr is result of a retrospective review of complaints. The reported event could not be confirmed as the device performed as intended. No anomalies were observed.
Patient Sequence No: 1, Text Type: N, H10


[183567005] On (b)(6) 2018, 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 Number3009862700-2020-00147
MDR Report Key9832561
Report SourceCONSUMER
Date Received2020-03-13
Date of Report2018-12-03
Date of Event2018-12-03
Date Mfgr Received2018-12-03
Device Manufacturer Date2018-08-03
Date Added to Maude2020-03-13
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 NameCONTINUOUS GLUCOSE MONITORING SYSTEM,
Product CodeQCD
Date Received2020-03-13
Returned To Mfg2019-01-03
Model Number102096-67A
Catalog NumberFG-4200-00-301
Lot NumberWP04528
Device Expiration Date2019-03-03
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerSENSEONICS INC.
Manufacturer Address20451 SENECA MEADOWS PARKWAY GERMANTOWN, MD US


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-13

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