FDA Adverse Event
Malfunction
Summary report: N
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
MDR report key: 16683118
·
Received April 5, 2023
Report
- Report Number
- 3013756811-2023-47472
- Event Type
- Malfunction
- Date Received
- April 5, 2023
- Date of Event
- February 25, 2023
- Report Date
- April 5, 2023
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- QFG
- UDI-DI
- 00850006613762
- PMA / PMN Number
- K201214
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 0
IT WAS REPORTED THAT AN OCCLUSION ALARM OCCURRED. CUSTOMER CHANGED SUPPLIES TO RESOLVE THE ISSUE. ADDITIONALLY, IT WAS REPORTED THAT INTERMITTENT MALFUNCTION ALARMS OCCURRED. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 100-204 MG/DL. CUSTOMER CONTINUED TO USE THE PUMP FOR INSULIN THERAPY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2254620 | 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 | 42 YR | Male | INSULIN: NOVOLOG / NOVORAPIDINFUSION SET: AUTOSOF |