FDA Adverse Event
Malfunction
Summary report: N
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
MDR report key: 15250668
·
Received August 18, 2022
Report
- Report Number
- 3013756811-2022-89016
- Event Type
- Malfunction
- Date Received
- August 18, 2022
- Date of Event
- July 27, 2022
- Report Date
- October 26, 2022
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- QFG
- UDI-DI
- 00850006613779
- PMA / PMN Number
- K201214
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
THE DEVICE IS EXPECTED TO BE RETURNED; HOWEVER, THE DEVICE HAS NOT YET BEEN RECEIVED.A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED AND EVALUATION IS PERFORMED.
Description of Event or Problem · 0
IT WAS REPORTED THAT A CARTRIDGE ALARM OCCURRED DURING INSULIN DELIVERY WITH MULTIPLE CARTRIDGES. THE CUSTOMER REVERTED TO MANUAL INJECTIONS FOR INSULIN THERAPY. CUSTOMER'S BLOOD GLUCOSE RANGED FROM APPROXIMATELY 200-330 MG/DL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2025130 | T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY | ALTERNATE CONTROLLER ENABLED INFUSION PUMP | QFG | TANDEM DIABETES CARE | 1002717 | W0239104 | 00850006613779 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 87 YR | Male |