FDA Adverse Event
Malfunction
Summary report: N
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
MDR report key: 14843157
·
Received June 28, 2022
Report
- Report Number
- 3013756811-2022-63362
- Event Type
- Malfunction
- Date Received
- June 28, 2022
- Date of Event
- June 5, 2022
- Report Date
- June 6, 2022
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- QFG
- PMA / PMN Number
- K201214
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
DEVICE NOT RETURNED.
Description of Event or Problem · 0
IT WAS REPORTED THAT INTERMITTENT OCCLUSION ALARMS OCCURRED. THE CUSTOMER USED THE CARTRIDGE AND INSULIN BEYOND LABELING. TANDEM TECHNICAL SUPPORT EDUCATED CUSTOMER REGARDING CARTRIDGE/INSULIN LABELING. REPORTEDLY, THE INFUSION SET WAS CHANGED TO ADDRESS THE ISSUE AND INSULIN DELIVERY WAS RESUMED. CUSTOMER'S BLOOD GLUCOSE RANGED FROM 111-352 MG/DL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2044336 | 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 | 23 YR | Female | INFUSION SET: TRUSTEEL, INSULIN: HUMALOG |