Brand Name | T:SLIM G5 SYSTEM |
Type of Device | CONTINUOUS GLUCOSE MONITOR |
Manufacturer (Section D) |
DEXCOM, INC. |
6340 sequence drive |
san diego CA 92121 |
|
Manufacturer (Section G) |
DEXCOM, INC. |
6340 sequence drive |
|
san diego CA 92121 |
|
Manufacturer Contact |
mick
trier
|
san diego, CA 92121
|
8584011451
|
|
MDR Report Key | 11186157 |
MDR Text Key | 229180207 |
Report Number | 3013756811-2021-09381 |
Device Sequence Number | 1 |
Product Code |
OYC
|
UDI-Device Identifier | 10386270000221 |
UDI-Public | (01)10386270000221 |
Combination Product (y/n) | N |
PMA/PMN Number | P140015 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
distributor |
Type of Report
| Initial |
Report Date |
01/18/2021 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 01/18/2021 |
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-001 |
Was Device Available for Evaluation? |
Yes
|
Was the Report Sent to FDA? |
Yes
|
Date Manufacturer Received | 01/05/2021 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Reuse
|
Patient Sequence Number | 1 |
|
|