FDA Adverse Event
Malfunction
Summary report: N
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
MDR report key: 10649043
·
Received October 8, 2020
Report
- Report Number
- 3013756811-2020-105476
- Event Type
- Malfunction
- Date Received
- October 8, 2020
- Date of Event
- September 8, 2020
- Report Date
- October 8, 2020
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- QFG
- UDI-DI
- 00850006613229
- PMA / PMN Number
- K201214
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PER THE TANDEM USER GUIDE: CHECK YOUR PUMP¿S PERSONAL SETTINGS REGULARLY TO ENSURE THEY ARE CORRECT. INCORRECT SETTINGS CAN RESULT IN OVER DELIVERY OR UNDER DELIVERY OF INSULIN. 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 CUSTOMER HAD THE INCORRECT PROFILE SETTING ACTIVATED. CUSTOMER'S BG WAS BETWEEN 152-192 MG/DL. CUSTOMER SWITCHED PERSONAL PROFILES AND DECLINED FURTHER TROUBLESHOOTING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1112543 | T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY | ALTERNATE CONTROLLER ENABLED INFUSION PUMP | QFG | TANDEM DIABETES CARE | 1002717 | 00850006613229 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR |