FDA Adverse Event
Malfunction
Summary report: N
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
MDR report key: 13599562
·
Received February 25, 2022
Report
- Report Number
- 3013756811-2022-18566
- Event Type
- Malfunction
- Date Received
- February 25, 2022
- Date of Event
- February 5, 2022
- Report Date
- February 25, 2022
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- QFG
- UDI-DI
- 00850006613762
- PMA / PMN Number
- K201214
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, 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 MULTIPLE CARTRIDGE ALARMS OCCURRED. IT WAS ALSO REPORTED THAT THE CARTRIDGE WAS LEAKING FROM THE O-RING. CUSTOMER¿S BLOOD GLUCOSE VALUE RANGED FROM 150-364 MG/DL. REPORTEDLY, A NEW CARTRIDGE WAS SUCCESSFULLY LOADED AFTER THE PUMP WAS RESET AND CUSTOMER RESUMED INSULIN DELIVERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1229517 | T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY | ALTERNATE CONTROLLER ENABLED INFUSION PUMP | QFG | TANDEM DIABETES CARE | 1002717 | 00850006613762 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 16 YR | Female |