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 | 11087542 |
MDR Text Key | 224060774 |
Report Number | 3013756811-2020-150587 |
Device Sequence Number | 1 |
Product Code |
OZO
|
UDI-Device Identifier | 00850006613380 |
UDI-Public | 00850006613380 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K201214 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
consumer |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
12/29/2020 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Lay User/Patient
|
Device Model Number | 1002717 |
Device Catalogue Number | 1005706 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
Yes
|
Initial Date Manufacturer Received |
12/21/2020 |
Initial Date FDA Received | 12/29/2020 |
Supplement Dates Manufacturer Received | 01/26/2021
|
Supplement Dates FDA Received | 01/27/2021
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 07/01/2020 |
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 Outcome(s) |
Other;
|
Patient Age | 56 YR |
Patient Weight | 80 |
|
|