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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 9445-02
Device Problem Wireless Communication Problem (3283)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/13/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
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.
 
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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 Key9772639
MDR Text Key181534269
Report Number3004753838-2020-020212
Device Sequence Number1
Product Code QBJ
UDI-Device Identifier00386270000385
UDI-Public00386270000385
Combination Product (y/n)N
Reporter Country CodeUK
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 02/29/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/29/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number9445-02
Device Catalogue NumberSTT-GS-003
Device Lot Number7266983
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received02/13/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/12/2019
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 Age13 YR
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