FDA Adverse Event
Malfunction
Summary report: N
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
MDR report key: 12739906
·
Received November 2, 2021
Report
- Report Number
- 3013756811-2021-116499
- Event Type
- Malfunction
- Date Received
- November 2, 2021
- Date of Event
- October 7, 2021
- Report Date
- November 2, 2021
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- QFG
- PMA / PMN Number
- K201214
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
NO PRODUCT WAS RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. DEVICE NOT RETURNED.
Description of Event or Problem · 1
IT WAS REPORTED THAT RESISTANCE WAS FELT WITH MULTIPLE CARTRIDGES WHEN FILLING THE CARTRIDGE DURING THE LOAD SEQUENCE. CUSTOMER CHANGED THE CARTRIDGE TO RESOLVE THE ISSUE. CUSTOMER¿S BLOOD GLUCOSE WAS 120-177 MG/DL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1637730 | 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 | 48 YR |