Brand Name | DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM |
Type of Device | MDS |
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 Key | 5278084 |
MDR Text Key | 33608586 |
Report Number | 3004753838-2015-66880 |
Device Sequence Number | 1 |
Product Code |
MDS
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | P120005 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
consumer |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
11/16/2015 |
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 Number | MT20649-BLU |
Device Catalogue Number | STR-GL-BLU |
Device Lot Number | 5196994 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 12/09/2015 |
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
11/16/2015 |
Initial Date FDA Received | 12/09/2015 |
Supplement Dates Manufacturer Received | Not provided
|
Supplement Dates FDA Received | 01/30/2016
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 07/01/2014 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Age | 59 YR |
Patient Weight | 93 |
|
|