FDA Adverse Event
Malfunction
Summary report: N
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
MDR report key: 15014912
·
Received July 14, 2022
Report
- Report Number
- 3013756811-2022-74624
- Event Type
- Malfunction
- Date Received
- July 14, 2022
- Date of Event
- June 24, 2022
- Report Date
- June 25, 2022
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- QFG
- UDI-DI
- 00850006613793
- PMA / PMN Number
- K201214
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
NO PRODUCT WAS RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 0
IT WAS REPORTED THAT A CARTRIDGE ALARM 05 OCCURRED. REPORTEDLY, THE CUSTOMER HAD FOLLOWED THE PROMPTS DURING THE LOAD SEQUENCE. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 220 - 265 MG/DL. A NEW CARTRIDGE WAS SUCCESSFULLY LOADED ONTO THE PUMP TO ADDRESS THE ALARM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 469322 | T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY | ALTERNATE CONTROLLER ENABLED INFUSION PUMP | QFG | TANDEM DIABETES CARE | 1000354 | 00850006613793 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 11 YR | Female |