FDA Adverse Event
Malfunction
Summary report: N
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
MDR report key: 9665210
·
Received February 4, 2020
Report
- Report Number
- 3013756811-2020-08413
- Event Type
- Malfunction
- Date Received
- February 4, 2020
- Date of Event
- January 5, 2020
- Report Date
- February 4, 2020
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- OZO
- UDI-DI
- 00853052007264
- PMA / PMN Number
- P180008
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE FAILURE INVESTIGATION HAS BEEN COMPLETED. BASED ON THE ANALYSIS, THE ALLEGED ISSUE WAS VERIFIED AND A DIFFERENT ISSUE WAS IDENTIFIED.
Description of Event or Problem · 1
IT WAS REPORTED THAT A CARTRIDGE ALARM 29 AND MULTIPLE CARTRIDGE ALARMS (ALARM 31) OCCURRED DURING BASAL DELIVERY AND THE LOAD SEQUENCE. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS BETWEEN 200-253 MG/DL. REPORTEDLY, THE CUSTOMER REVERTED TO AN ALTERNATE METHOD OF INSULIN DELIVERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 128375 | 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 | 49 YR |