Brand Name | DEXCOM G-6 |
Type of Device | SENSOR, GLUCOSE, INVASIVE |
Manufacturer (Section D) |
|
MDR Report Key | 10894235 |
MDR Text Key | 218204455 |
Report Number | MW5098038 |
Device Sequence Number | 1 |
Product Code |
MDS
|
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Voluntary
|
Reporter Occupation |
Patient
|
Type of Report
| Initial |
Report Date |
11/20/2020 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 11/23/2020 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Lay User/Patient
|
Device Model Number | G-6 |
Was Device Available for Evaluation? |
Yes
|
Was Device Evaluated by Manufacturer? |
No Information
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
Required Intervention;
|
Patient Age | 67 YR |
Patient Weight | 95 |
|
|