FDA Adverse Event
Malfunction
Summary report: N
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
MDR report key: 8343269
·
Received February 15, 2019
Report
- Report Number
- 3013756811-2019-05969
- Event Type
- Malfunction
- Date Received
- February 15, 2019
- Date of Event
- January 5, 2019
- Report Date
- February 15, 2019
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- OZO
- UDI-DI
- 00853052007264
- PMA / PMN Number
- P180008
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE T:SLIM X2G6 USER GUIDE STATES: ALWAYS REMOVE ALL AIR BUBBLES BEFORE BEGINNING INSULIN DELIVERY. 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 AIR BUBBLES WERE OBSERVED WITHIN THE TUBING. REPORTEDLY, THE CUSTOMER HAD NOT PERFORMED THE AIR REMOVAL PROCESS. A CARTRIDGE CHANGE WAS PERFORMED RESOLVING THE AIR BUBBLES. TANDEM TECHNICAL SUPPORT EDUCATED THE CUSTOMER REGARDING THE PROPER AIR REMOVAL PROCESS. CUSTOMER'S BLOOD GLUCOSE LEVEL RANGED BETWEEN 190-220 MG/DL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 137488 | T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY | AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND | OZO | TANDEM DIABETES CARE | 1000096 | 00853052007264 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 38 YR | INFUSION SET: AUTOSOFT 30, INSULIN: HUMALOG |