Brand Name | DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM |
Type of Device | CONTINUOUS GLUCOSE MONITOR |
Manufacturer (Section D) |
DEXCOM, INC. |
6340 sequence dr. |
san diego CA 92121 |
|
Manufacturer Contact |
ashley
spoto
|
6340 sequence dr. |
san diego, CA 92121
|
8582000200
|
|
MDR Report Key | 10009365 |
MDR Text Key | 189331994 |
Report Number | 3004753838-2020-039748 |
Device Sequence Number | 1 |
Product Code |
MDS
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
consumer,distributor |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
09/28/2020 |
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 | MT20649-1 |
Device Catalogue Number | STK-GL-012 |
Device Lot Number | 5253192 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 07/23/2020 |
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
04/07/2020 |
Initial Date FDA Received | 04/29/2020 |
Supplement Dates Manufacturer Received | 09/06/2020
|
Supplement Dates FDA Received | 09/28/2020
|
Was Device Evaluated by Manufacturer? |
Yes
|
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Patient Age | 37 YR |
Patient Weight | 65 |
|
|