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 | 9662485 |
MDR Text Key | 177541534 |
Report Number | 3004753838-2020-011365 |
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 |
distributor,foreign |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
02/05/2020 |
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 | MT20649-3 |
Device Catalogue Number | STR-JP-001 |
Device Lot Number | 5247821 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 01/28/2020 |
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
01/06/2020 |
Initial Date FDA Received | 02/03/2020 |
Supplement Dates Manufacturer Received | 02/05/2020
|
Supplement Dates FDA Received | 02/05/2020
|
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
|
Patient Sequence Number | 1 |
Patient Age | 118 YR |
|
|