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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 09/29/2020
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 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.
 
Event Description
Subsequent to the initial mdr, additional information is available and a correction is required.
 
Manufacturer Narrative
(b)(4).B5: describe event or problem - additional/correction d4: additional device information - additional/correction h2: additional information/correction.
 
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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
MDR Report Key10767598
MDR Text Key214153230
Report Number3004753838-2020-128614
Device Sequence Number1
Product Code QBJ
UDI-Device Identifier00386270000385
UDI-Public00386270000385
Combination Product (y/n)N
PMA/PMN Number
DEN170088
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial,Followup
Report Date 12/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
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-OE-002
Device Lot Number5277360
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 10/07/2020
Initial Date FDA Received10/31/2020
Supplement Dates Manufacturer Received12/10/2020
Supplement Dates FDA Received12/10/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age59 YR
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