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U.S. Department of Health and Human Services

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

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DEXCOM, INC. DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM Back to Search Results
Model Number MT20649-2
Device Problem Unexpected Shutdown (4019)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/02/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that unexpected receiver shut-down 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).
 
Event Description
The product was evaluated. The device was externally visually inspected and it passed. The receiver was able to be charged and rebooted. The log was downloaded and reviewed finding no errors related to the complaint. Manual tests were performed and the tests passed. Functional testing was performed and it passed. The receiver case was opened and the internal inspection passed. The allegation was not confirmed. The root cause could not be determined.
 
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Brand NameDEXCOM G4 PLATINUM 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 Key8476487
MDR Text Key140805491
Report Number3004753838-2019-31215
Device Sequence Number1
Product Code MDS
Combination Product (y/n)N
Reporter Country CodeNO
PMA/PMN Number
P120005
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/02/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/02/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMT20649-2
Device Catalogue NumberSTK-GL-117
Device Lot Number5241960
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/22/2019
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/31/2019
Was Device Evaluated by Manufacturer? Yes
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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