Brand Name | T:SLIM X2 INSULIN PUMP |
Type of Device | PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR |
Manufacturer (Section D) |
TANDEM DIABETES CARE |
11075 roselle street |
san diego CA 92121 |
|
Manufacturer Contact |
julia
kensick
|
11075 roselle st. |
san diego, CA 92121
|
8583666900
|
|
MDR Report Key | 8781029 |
MDR Text Key | 150744133 |
Report Number | 3013756811-2019-38957 |
Device Sequence Number | 1 |
Product Code |
OYC
|
Combination Product (y/n) | N |
PMA/PMN Number | P140015 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
distributor |
Type of Report
| Initial,Followup |
Report Date |
07/11/2019 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 07/11/2019 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Lay User/Patient
|
Device Model Number | 1002717 |
Device Catalogue Number | 1002682 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 08/14/2019 |
Was the Report Sent to FDA? |
Yes
|
Date Manufacturer Received | 09/06/2019 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 04/01/2019 |
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 |
|
|