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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G4 PLATINUM PROFESSIONAL CONTINUOUS GLUCOSE MONITORING SYSTEM

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DEXCOM, INC. DEXCOM G4 PLATINUM PROFESSIONAL CONTINUOUS GLUCOSE MONITORING SYSTEM Back to Search Results
Model Number MT20649
Device Problem No Audible Alarm (1019)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/17/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the receiver had no audio output occurred. No product or data was provided for evaluation. Confirmation of the allegation and a root cause could not be determined. No injury or medical intervention was reported.
 
Manufacturer Narrative
(b)(4).
 
Manufacturer Narrative
(b)(4). No product returned.
 
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Brand NameDEXCOM G4 PLATINUM PROFESSIONAL CONTINUOUS GLUCOSE MONITORING SYSTEM
Type of DeviceCONTINUOUS GLUCOSE MONITOR
Manufacturer (Section D)
DEXCOM, INC.
6340 sequence drive
san diego CA 92121
Manufacturer (Section G)
DEXCOM, INC.
6340 sequence drive
san diego CA 92121
Manufacturer Contact
ying chen
6340 sequence drive
san diego, CA 92121
8582000200
MDR Report Key9310421
MDR Text Key166705750
Report Number3004753838-2019-85152
Device Sequence Number1
Product Code MDS
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P120005
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 11/13/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/12/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMT20649
Device Catalogue NumberSTK-PU-001
Device Lot Number5204333
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/13/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/24/2015
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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