Brand Name | DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM |
Type of Device | SENSOR, GLUCOSE, INVASIVE |
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 | 9376267 |
MDR Text Key | 168036575 |
Report Number | 3013756811-2019-87188 |
Device Sequence Number | 1 |
Product Code |
MDS
|
UDI-Device Identifier | 00386270000040 |
UDI-Public | 00386270000040 |
Combination Product (y/n) | N |
Reporter Country Code | CA |
PMA/PMN Number | P120005 |
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 |
11/26/2019 |
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-005 |
Was Device Available for Evaluation? |
No
|
Was the Report Sent to FDA? |
Yes
|
Initial Date Manufacturer Received |
11/08/2019 |
Initial Date FDA Received | 11/26/2019 |
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 |
Patient Age | 11 YR |
|
|