FDA Adverse Event
Malfunction
Summary report: N
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
MDR report key: 8952084
·
Received August 30, 2019
Report
- Report Number
- 3013756811-2019-54205
- Event Type
- Malfunction
- Date Received
- August 30, 2019
- Date of Event
- August 8, 2019
- Report Date
- August 30, 2019
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- OZO
- UDI-DI
- 00853052007264
- PMA / PMN Number
- P180008
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT INTERMITTENT CARTRIDGE ALARMS OCCURRED (CARTRIDGE ALARM 30 AND CARTRIDGE ALARM 29) WITH MULTIPLE CARTRIDGES DURING LOAD AND BASAL DELIVERY. CUSTOMERS' BLOOD GLUCOSE LEVEL WAS 180-217 MG/DL. CUSTOMER DECLINED TO COMPLETE TROUBLESHOOTING WITH TANDEM TECHNICAL SUPPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT INTERMITTENT CARTRIDGE ALARMS OCCURRED (CARTRIDGE ALARM 30 AND CARTRIDGE ALARM 29) WITH MULTIPLE CARTRIDGES DURING THE LOAD SEQUENCE. CUSTOMERS' BLOOD GLUCOSE LEVEL WAS 180-217 MG/DL. CUSTOMER DECLINED TO COMPLETE TROUBLESHOOTING WITH TANDEM TECHNICAL SUPPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 743718 | 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 |