Brand Name | DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM |
Type of Device | CONTINUOUS GLUCOSE MONITOR |
Manufacturer (Section D) |
DEXCOM, INC. |
6340 sequence drive |
san diego, ca CA 92121 |
|
MDR Report Key | 9241999 |
MDR Text Key | 172436231 |
Report Number | 3004753838-2019-75945 |
Device Sequence Number | 1 |
Product Code |
MDS
|
Combination Product (y/n) | N |
PMA/PMN Number | P120005 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
distributor,foreign |
Type of Report
| Initial,Followup,Followup |
Report Date |
06/05/2020 |
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 | MT20649-2 |
Device Catalogue Number | STK-GL-112 |
Device Lot Number | 5223605 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 11/01/2019 |
Initial Date Manufacturer Received |
09/27/2019 |
Initial Date FDA Received | 10/25/2019 |
Supplement Dates Manufacturer Received | 11/09/2019 05/29/2020
|
Supplement Dates FDA Received | 12/04/2019 06/05/2020
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Treatment | NI.; NI. |
|
|