FDA Adverse Event
Malfunction
Summary report: N
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
MDR report key: 11015422
·
Received December 16, 2020
Report
- Report Number
- 3013756811-2020-142889
- Event Type
- Malfunction
- Date Received
- December 16, 2020
- Date of Event
- November 30, 2020
- Report Date
- December 15, 2020
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- OZO
- UDI-DI
- 00850006613021
- PMA / PMN Number
- K201214
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PER THE CARTRIDGE INSTRUCTIONS FOR USE: MAKE SURE THAT INSULIN IS AT ROOM TEMPERATURE BEFORE FILLING THE CARTRIDGE. NO PRODUCT WAS RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT AN OCCLUSION ALARM OCCURRED. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 251-318 MG/DL. REPORTEDLY, CUSTOMER WAS USING COLD INSULIN. CUSTOMER LOADED A CARTRIDGE WITH ROOM-TEMPERATURE INSULIN TO RESOLVE THE ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1482107 | T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY | AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND | OZO | TANDEM DIABETES CARE | 1002717 | 00850006613021 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 19 YR | INSULIN TYPE: NOVOLOG / NOVORAPID. |