DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM 9445-02 STT-GS-003

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign report with the FDA on 2020-03-31 for DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM 9445-02 STT-GS-003 manufactured by Dexcom, Inc..

Event Text Entries

[186746663] (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[186746664] It was reported that signal loss over one hour occurred. A review of the share logs was performed and a loss of connection was found within the investigation window. However, the device operated within specification. The allegation was not confirmed. The probable cause could not be determined. No injury or medical intervention was reported.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3004753838-2020-031182
MDR Report Key9908638
Report SourceCONSUMER,FOREIGN
Date Received2020-03-31
Date of Report2020-03-31
Date of Event2020-03-18
Date Mfgr Received2020-03-18
Device Manufacturer Date2019-09-07
Date Added to Maude2020-03-31
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 G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
Generic NameCONTINUOUS GLUCOSE MONITOR
Product CodeQBJ
Date Received2020-03-31
Model Number9445-02
Catalog NumberSTT-GS-003
Lot Number7260522
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerDEXCOM, INC.
Manufacturer Address6340 SEQUENCE DR. SAN DIEGO CA 92121 US 92121


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-31

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