FDA Adverse Event
Malfunction
Summary report: N
SOFTCLIX ® LANCET DEVICE
MDR report key: 23682523
·
Received December 1, 2025
Report
- Report Number
- 3011393376-2025-01135
- Event Type
- Malfunction
- Date Received
- December 1, 2025
- Report Date
- December 9, 2025
- Manufacturer
- ROCHE DIABETES CARE, INC.
- Product Code
- QRL
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
CHAPTER D 4 WAS UPDATED BASED ON THE RETURNED PRODUCT.
Additional Manufacturer Narrative · 0
THE EVENT OCCURRED OUTSIDE OF THE UNITED STATES WHILE THIS PRODUCT IS NOT SOLD IN THE UNITED STATES, IT IS LIKE OR SIMILAR TO A PRODUCT MARKETED IN THE UNITED STATES.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE LANCET PROTRUDES BEYOND THE END CAP OF THE DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2080035 | SOFTCLIX ® LANCET DEVICE | LANCET DEVICE | QRL | ROCHE DIABETES CARE, INC. | BAY051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female |