FDA Adverse Event
Malfunction
Summary report: N
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
MDR report key: 12540819
·
Received September 28, 2021
Report
- Report Number
- 3013756811-2021-101144
- Event Type
- Malfunction
- Date Received
- September 28, 2021
- Date of Event
- September 7, 2021
- Report Date
- September 28, 2021
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- QFG
- UDI-DI
- 00850006613205
- PMA / PMN Number
- K201214
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE NOT RETURNED.
Description of Event or Problem · 1
IT WAS REPORTED THAT A MALFUNCTION ALARM OCCURRED. DURING TROUBLESHOOTING WITH TANDEM TECHNICAL SUPPORT, THE MALFUNCTION ALARM WAS CLEARED, AND INSULIN DELIVERY WAS RESUMED SUCCESSFULLY. SUBSEQUENTLY, THE PUMP TIME AND DATE WERE INCORRECT. TANDEM TECHNICAL SUPPORT ASSISTED CUSTOMER IN CORRECTING PUMP TIME, AND CUSTOMER RESUMED INSULIN THERAPY. CUSTOMER'S BLOOD GLUCOSE RANGED FROM 150-227 MG/DL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1436085 | T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY | ALTERNATE CONTROLLER ENABLED INFUSION PUMP | QFG | TANDEM DIABETES CARE | 1002717 | 00850006613205 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | INFUSION SET: AUTOSOFT 90, INSULIN: NOVOLOG |