FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® FASTCLIX
MDR report key: 23322866
·
Received October 17, 2025
Report
- Report Number
- 3011393376-2025-01023
- Event Type
- Malfunction
- Date Received
- October 17, 2025
- Date of Event
- October 9, 2025
- Report Date
- November 14, 2025
- Manufacturer
- ROCHE DIABETES CARE, INC.
- Product Code
- QRL
- UDI-DI
- 00365702481107
- PMA / PMN Number
- K220608
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
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 |
|---|---|---|---|---|---|---|---|
| 300430 | ACCU-CHEK ® FASTCLIX | LANCET DEVICE | QRL | ROCHE DIABETES CARE, INC. | 33324026 | 00365702481107 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 43 YR | Female |