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 | 12505817 |
MDR Text Key | 273558408 |
Report Number | 3004753838-2021-163831 |
Device Sequence Number | 1 |
Product Code |
MDS
|
Combination Product (y/n) | N |
Reporter Country Code | GM |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
consumer,foreign |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
09/21/2021 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 09/21/2021 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Lay User/Patient
|
Device Expiration Date | 02/07/2022 |
Device Catalogue Number | STK-GF-013 |
Device Lot Number | 5286502 |
Was Device Available for Evaluation? |
No
|
Was the Report Sent to FDA? |
No
|
Date Manufacturer Received | 09/20/2021 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 02/12/2021 |
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 | 42 YR |
|
|