Brand Name | DIABETES PUMP |
Type of Device | PUMP, INFUSION, INSULIN |
Manufacturer (Section D) |
TANDEM DIABETES CARE, INC. |
|
|
MDR Report Key | 10903244 |
MDR Text Key | 218518041 |
Report Number | MW5098081 |
Device Sequence Number | 1 |
Product Code |
LZG
|
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 |
11/21/2020 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 11/24/2020 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Lay User/Patient
|
Was Device Available for Evaluation? |
No
|
Was Device Evaluated by Manufacturer? |
No Information
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
Patient Age | 72 YR |
Patient Weight | 76 |
|
|