Brand Name | T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY |
Type of Device | AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND |
Manufacturer (Section D) |
TANDEM DIABETES CARE |
11075 roselle street |
san diego CA 92121 |
|
Manufacturer Contact |
mick
trier
|
san diego, CA 92121
|
8584011451
|
|
MDR Report Key | 14204719 |
MDR Text Key | 290300606 |
Report Number | 3013756811-2022-42482 |
Device Sequence Number | 1 |
Product Code |
OZO
|
Combination Product (y/n) | N |
Reporter Country Code | NO |
PMA/PMN Number | K201214 |
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 |
04/07/2022 |
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 Model Number | 1002717 |
Device Catalogue Number | 1002684-A |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
Yes
|
Initial Date Manufacturer Received |
04/07/2022 |
Initial Date FDA Received | 04/26/2022 |
Supplement Dates Manufacturer Received | 07/08/2022
|
Supplement Dates FDA Received | 07/12/2022
|
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 |
Patient Ethnicity | Non Hispanic |
|
|