Brand Name | T:SLIM X2, BASAL-IQ, MMOL/L |
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 | 9750871 |
MDR Text Key | 180755945 |
Report Number | 3013756811-2020-18695 |
Device Sequence Number | 1 |
Product Code |
OZO
|
Combination Product (y/n) | N |
Reporter Country Code | CA |
PMA/PMN Number | P180008 |
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 |
02/25/2020 |
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? |
Yes
|
Device Operator |
Lay User/Patient
|
Device Model Number | 1002717 |
Device Catalogue Number | 1002684 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 04/16/2020 |
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
Yes
|
Initial Date Manufacturer Received |
02/07/2020 |
Initial Date FDA Received | 02/25/2020 |
Supplement Dates Manufacturer Received | 05/04/2020
|
Supplement Dates FDA Received | 05/04/2020
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 06/01/2019 |
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 |
Treatment | INSULIN: NOVOLOG/NOVORAPID, INFUSION SET: AUTOSOFT |
Patient Outcome(s) |
Other;
|
Patient Age | 58 YR |
|
|