Brand Name | DEXCOM G6 GLUCOSE PROGRAM CONTINUOUS GLUCOSE MONITORING (CGM) 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 | 13078675 |
MDR Text Key | 282723394 |
Report Number | 3004753838-2021-433270 |
Device Sequence Number | 1 |
Product Code |
QDK
|
Combination Product (y/n) | Y |
Reporter Country Code | US |
PMA/PMN Number | K203089 |
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 |
12/23/2021 |
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 | 12/31/2022 |
Device Model Number | 9445-24 |
Device Catalogue Number | STS-OR-003#S-P#50386270000250 |
Device Lot Number | 7292534 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
12/06/2021
|
Initial Date FDA Received | 12/23/2021 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 06/15/2021 |
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 | 67 YR |
Patient Sex | Female |
Patient Weight | 60 KG |