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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 N/A
Device Problem Wireless Communication Problem (3283)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/18/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that signal loss over one hour occurred.It was indicated that the operating system for the smart device was not a supported system, which is off-label usage of the device.It was determined that the loss of connection was related to the mobile application.A review of the share logs was performed and a loss of connection was not found within the investigation window.The allegation was not confirmed.The probable cause could not be determined.No injury or medical intervention was reported.
 
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Brand Name
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
Type of Device
CONTINUOUS 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 Key9656046
MDR Text Key177354255
Report Number3004753838-2020-010721
Device Sequence Number1
Product Code QBJ
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
DEN170088
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign
Reporter Occupation Other
Type of Report Initial
Report Date 01/31/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/31/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberN/A
Device Catalogue NumberSW11585
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received01/18/2020
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
Patient Sequence Number1
Patient Age11 YR
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