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 | 12954537 |
MDR Text Key | 282226379 |
Report Number | 3013756811-2021-135988 |
Device Sequence Number | 1 |
Product Code |
OZO
|
UDI-Device Identifier | 00850006613021 |
UDI-Public | (01)00850006613021 |
Combination Product (y/n) | N |
Reporter Country Code | GB |
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 |
11/29/2021 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 12/07/2021 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Model Number | 1002717 |
Device Catalogue Number | 1004223 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
Yes
|
Date Manufacturer Received | 05/07/2022 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 07/01/2019 |
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 |
|
|