FDA Adverse Event
Malfunction
Summary report: N
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
MDR report key: 17051793
·
Received June 2, 2023
Report
- Report Number
- 3013756811-2023-75590
- Event Type
- Malfunction
- Date Received
- June 2, 2023
- Date of Event
- May 12, 2023
- Report Date
- June 2, 2023
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- QFG
- UDI-DI
- 00389152000107
- PMA / PMN Number
- K201214
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, 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. H3 OTHER TEXT : DEVICE NOT RETURNED.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE INSULIN GAUGE WAS INACCURATE. CUSTOMER LOADED A NEW CARTRIDGE TO RESOLVE THE ISSUE. IT WAS ALSO REPORTED THAT THE BATTERY GAUGE WAS FLUCTUATING. THE CUSTOMER CONTINUED TO USE THE PUMP FOR INSULIN THERAPY. THE CUSTOMER'S BLOOD GLUCOSE WAS 140 - 151 MG/DL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1621488 | T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY | ALTERNATE CONTROLLER ENABLED INFUSION PUMP | QFG | TANDEM DIABETES CARE | 1000354 | 00389152000107 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Male |