Brand Name | CGM SENSOR |
Type of Device | SENSOR, GLUCOSE, INVASIVE |
Manufacturer (Section D) |
|
MDR Report Key | 12583854 |
MDR Text Key | 275374880 |
Report Number | MW5104430 |
Device Sequence Number | 1 |
Product Code |
MDS
|
UDI-Device Identifier | 00386270000255 |
UDI-Public | (01)00386270000255 |
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 |
10/03/2021 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 10/05/2021 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Lay User/Patient
|
Device Expiration Date | 11/30/2022 |
Device Model Number | 9500-45 |
Device Lot Number | 7291479 |
Was Device Available for Evaluation? |
No
|
Was Device Evaluated by Manufacturer? |
No Information
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
|
|