DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM 9438-06 STT-MC-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 2019-11-30 for DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM 9438-06 STT-MC-001 manufactured by Dexcom, Inc..

MAUDE Entry Details

Report Number3004753838-2019-097090
MDR Report Key9392481
Report SourceCONSUMER
Date Received2019-11-30
Date of Report2019-11-30
Date of Event2019-11-01
Date Mfgr Received2019-11-13
Device Manufacturer Date2019-07-24
Date Added to Maude2019-11-30
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 ASHLEY SPOTO
Manufacturer Street6340 SEQUENCE DR.
Manufacturer CitySAN DIEGO CA 92121
Manufacturer CountryUS
Manufacturer Postal92121
Manufacturer Phone8582000200
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameDEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
Generic NameCONTINUOUS GLUCOSE MONITOR
Product CodePQF
Date Received2019-11-30
Returned To Mfg2019-11-08
Model Number9438-06
Catalog NumberSTT-MC-001
Lot Number7258568
OperatorLAY USER/PATIENT
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerDEXCOM, INC.
Manufacturer Address6340 SEQUENCE DR. SAN DIEGO CA 92121 US 92121


Patients

Patient NumberTreatmentOutcomeDate
10 2019-11-30

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