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 | 8110991 |
MDR Text Key | 128610485 |
Report Number | 3013756811-2018-41638 |
Device Sequence Number | 1 |
Product Code |
OYC
|
Combination Product (y/n) | N |
Reporter Country Code | IT |
PMA/PMN Number | P140015 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
distributor |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
11/28/2018 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
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 | 03/27/2019 |
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
Yes
|
Initial Date Manufacturer Received |
11/14/2018 |
Initial Date FDA Received | 11/28/2018 |
Supplement Dates Manufacturer Received | 05/10/2019
|
Supplement Dates FDA Received | 05/13/2019
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 10/01/2018 |
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 |
|
|