FDA Adverse Event
Malfunction
Summary report: N
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
MDR report key: 18031125
·
Received October 30, 2023
Report
- Report Number
- 3013756811-2023-152264
- Event Type
- Malfunction
- Date Received
- October 30, 2023
- Date of Event
- October 7, 2023
- Report Date
- October 30, 2023
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- QFG
- PMA / PMN Number
- K201214
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- 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. H3 OTHER TEXT : DEVICE NOT RETURNED.
Description of Event or Problem · 0
IT WAS REPORTED THAT AN O-RING WAS ON THE PNEUMATIC TAP. THE CUSTOMER WAS ABLE TO REMOVE THE O-RING FROM THE PUMP AND SUCCESSFULLY RELOADED THE EXISTING CARTRIDGE TO RESUME INSULIN THERAPY. ADDITIONALLY, IT WAS REPORTED THAT AN ALTITUDE ALARM OCCURRED WHILE THE PUMP WAS NOT OUTSIDE THE LABELED ALTITUDE OPERATING RANGE. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 251-271 MG/DL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1928389 | T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY | ALTERNATE CONTROLLER ENABLED INFUSION PUMP | QFG | TANDEM DIABETES CARE | 1002717 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 28 YR | Male | INSULIN TYPE- NOVOLOG/NOVORAPID |