Brand Name | DEXCOM G6 SENSOR |
Type of Device | SENSOR, GLUCOSE, INVASIVE |
Manufacturer (Section D) |
|
MDR Report Key | 15606207 |
MDR Text Key | 301933704 |
Report Number | MW5112634 |
Device Sequence Number | 1 |
Product Code |
MDS
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Voluntary
|
Reporter Occupation |
Unknown
|
Type of Report
| Initial |
Report Date |
10/12/2022 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Lay User/Patient
|
Was Device Available for Evaluation? |
Yes
|
Initial Date Manufacturer Received |
Not provided |
Initial Date FDA Received | 10/13/2022 |
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|
Patient Age | 56 YR |
Patient Sex | Female |
Patient Weight | 80 KG |
Patient Ethnicity | Non Hispanic |
Patient Race | White |
|
|