FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® FASTCLIX
MDR report key: 23366748
·
Received October 23, 2025
Report
- Report Number
- 3011393376-2025-01036
- Event Type
- Malfunction
- Date Received
- October 23, 2025
- Date of Event
- October 10, 2025
- Report Date
- March 3, 2026
- Manufacturer
- ROCHE DIABETES CARE, INC.
- Product Code
- QRL
- UDI-DI
- 00365702288102
- PMA / PMN Number
- K220608
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Description of Event or Problem · 0
IT WAS REPORTED THAT THE NEEDLES ARE EXPOSED/VISIBLE. THE LANCETS WERE EXPOSED FROM THE DRUM OUT OF THE BOX AS THE NEEDLES WERE VISIBLE. THE SEAL OF THE BOX WAS BROKEN AS WELL. THE CUSTOMER SAID THAT THE DEFECT WAS APPARENT WHEN HE RECEIVED THE PRODUCT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2730610 | ACCU-CHEK ® FASTCLIX | LANCET DEVICE | QRL | ROCHE DIABETES CARE, INC. | WPL126A | 00365702288102 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | Male |