FDA Adverse Event
Malfunction
Summary report: N
SOFTCLIX ® LANCETS
MDR report key: 23494347
·
Received November 7, 2025
Report
- Report Number
- 3011393376-2025-01067
- Event Type
- Malfunction
- Date Received
- November 7, 2025
- Date of Event
- October 31, 2025
- Report Date
- November 26, 2025
- Manufacturer
- ROCHE DIABETES CARE, INC.
- Product Code
- QRK
- UDI-DI
- 04015630084937
- PMA / PMN Number
- K214022
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Description of Event or Problem · 0
IT WAS REPORTED THAT THE LANCET WAS ALREADY ON THE LANCING DEVICE WITHOUT THE CAP. PACKAGE WAS OPEN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1848478 | SOFTCLIX ® LANCETS | LANCET | QRK | ROCHE DIABETES CARE, INC. | 10825032 | 04015630084937 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female |