FDA Adverse Event
Malfunction
Summary report: N
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
MDR report key: 17661984
·
Received August 31, 2023
Report
- Report Number
- 3013756811-2023-125219
- Event Type
- Malfunction
- Date Received
- August 31, 2023
- Date of Event
- August 22, 2023
- Report Date
- October 26, 2023
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- QFG
- PMA / PMN Number
- K201214
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
THE DEVICE IS EXPECTED TO BE RETURNED; HOWEVER, THE DEVICE HAS NOT YET BEEN RECEIVED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED AND EVALUATION IS PERFORMED.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE WAKE BUTTON IS DIFFICULT TO PRESS AND REQUIRES MULTIPLE PRESSES TO TURN ON PUMP SCREEN. CUSTOMER CONTINUED USING THE PUMP FOR INSULIN THERAPY. CUSTOMER'S BLOOD GLUCOSE LEVEL RANGED FROM 161-162 MG/DL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1189939 | 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 | 14 YR | Female |