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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 Overheating of Device (1437)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/24/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The patient experienced adverse events on different days with the same device. The following reports are being submitted. (b)(4).
 
Event Description
Dexcom was made aware on (b)(4) 2018 , that on (b)(6) 2018 , the receiver was overheating. No additional event or patient information is available. No product or data was provided for evaluation. The complaint confirmation of the overheating of the receiver could not be determined. A root cause could not be determined.
 
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the receiver was overheating. The device was externally visually inspected and it failed due to damaged usb pins from j3. The receiver failed to charge and reboot due to the damaged usb pins from j3. The receiver log download and functional testing were unable to be performed due to damaged usb pins from j3. The receiver case was opened for an internal visual inspection and it passeed. Confirmation of the allegation and a root cause could not be determined. No injury or medical intervention was reported.
 
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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
kipp durbin
6340 sequence drive
san diego, CA 92121
8582000200
MDR Report Key8182425
MDR Text Key131312950
Report Number3004753838-2018-159614
Device Sequence Number1
Product Code MDS
Combination Product (y/n)N
Reporter Country CodeSZ
PMA/PMN Number
P120005
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/26/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/19/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMT20649-2
Device Catalogue NumberSTR-GL-102
Device Lot Number5220724
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/13/2019
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/27/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/17/2016
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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