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 | 5449391 |
MDR Text Key | 38636326 |
Report Number | 3004753838-2016-05904 |
Device Sequence Number | 1 |
Product Code |
MDS
|
UDI-Device Identifier | 00386270000019 |
UDI-Public | (01)00386270000019(241)9500-27(10)5202460(17)160720 |
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 |
Report Date |
01/26/2016 |
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 Expiration Date | 07/20/2016 |
Device Model Number | 9500-27 |
Device Catalogue Number | STS-GL-011 |
Device Lot Number | 5202460 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
01/26/2016 |
Initial Date FDA Received | 02/19/2016 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 07/21/2015 |
Is the Device Single Use? |
Yes
|
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 | 91 |