FDA Adverse Event
Malfunction
Summary report: N
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
MDR report key: 18080505
·
Received November 6, 2023
Report
- Report Number
- 3013756811-2023-158550
- Event Type
- Malfunction
- Date Received
- November 6, 2023
- Date of Event
- October 16, 2023
- Report Date
- January 18, 2024
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- QFG
- UDI-DI
- 00850006613762
- PMA / PMN Number
- K201214
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, 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 AN ALTITUDE ALARM OCCURRED. REPORTEDLY, THE PUMP WAS NOT OUTSIDE THE LABELED ALTITUDE OPERATING RANGE. THE CUSTOMER'S BLOOD GLUCOSE WAS 201-240 MG/DL. REPORTEDLY, THE CUSTOMER WILL CONTINUE TO USE CURRENT PUMP FOR INSULIN THERAPY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1209200 | 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 | 30 YR | Female |