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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

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DEXCOM, INC. DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM Back to Search Results
Model Number MT24078-2
Device Problem Wireless Communication Problem (3283)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/02/2020
Event Type  Malfunction  
Manufacturer Narrative

(b)(4).

 
Event Description

It was reported that signal loss over one hour occurred. Data has been received but is pending evaluation. A follow up report will be submitted upon completion. No injury or medical intervention was reported.

 
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Brand NameDEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
Type of DeviceCONTINUOUS GLUCOSE MONITOR
Manufacturer (Section D)
DEXCOM, INC.
6340 sequence dr.
san diego CA 92121
Manufacturer Contact
ashley spoto
6340 sequence dr.
san diego, CA 92121
8582000200
MDR Report Key10475040
MDR Text Key205084873
Report Number3004753838-2020-097217
Device Sequence Number1
Product Code QBJ
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberDEN170088
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER,FOREIGN
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/08/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/31/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL NumberMT24078-2
Device Catalogue NumberSTK-GS-109
Device LOT Number5259156
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/04/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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