FDA Adverse Event
Malfunction
Summary report: N
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
MDR report key: 11475622
·
Received March 12, 2021
Report
- Report Number
- 3013756811-2021-29422
- Event Type
- Malfunction
- Date Received
- March 12, 2021
- Date of Event
- January 1, 2021
- Report Date
- March 12, 2021
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- QFG
- UDI-DI
- 00850006613786
- PMA / PMN Number
- K201214
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, 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.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE CARTRIDGE NEEDED TO BE CHANGED EARLY FOR AN UNKNOWN REASON. TANDEM TECHNICAL SUPPORT WAS UNABLE TO VERIFY ANY ALARMS OCCURRED IN THE PUMP HISTORY. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 200-235 MG/DL. CUSTOMER CHANGED CARTRIDGE TO ADDRESS THE ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 367909 | T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY | ALTERNATE CONTROLLER ENABLED INFUSION PUMP | QFG | TANDEM DIABETES CARE | 1002717 | 00850006613786 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR |