Brand Name | DEXCOM G5 MOBILE 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 | 9656107 |
MDR Text Key | 177354651 |
Report Number | 3004753838-2020-010740 |
Device Sequence Number | 1 |
Product Code |
PQF
|
Combination Product (y/n) | N |
Reporter Country Code | AS |
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 |
06/26/2020 |
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 | 9438-06 |
Device Catalogue Number | STT-GF-004 |
Device Lot Number | 5261192 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 06/08/2020 |
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
01/05/2020 |
Initial Date FDA Received | 01/31/2020 |
Supplement Dates Manufacturer Received | 06/21/2020
|
Supplement Dates FDA Received | 06/26/2020
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 09/03/2019 |
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 | 14 YR |
|
|