FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® FASTCLIX
MDR report key: 3191474
·
Received June 26, 2013
Report
- Report Number
- 1823260-2013-03891
- Event Type
- Malfunction
- Date Received
- June 26, 2013
- Date of Event
- June 4, 2013
- Report Date
- July 29, 2025
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- FMK
- PMA / PMN Number
- EXEMPT
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 1
THE EVENT OCCURRED IN (B)(6). THE YEAR IS THE ONLY KNOWN PART OF MANUFACTURE DATE. WE HAVE DEFAULTED TO THE FIRST OF THE YEAR.
Additional Manufacturer Narrative · 1
THE EVENT OCCURRED IN (B)(6).
Description of Event or Problem · 1
REPORTER STATED LANCET PROTRUDES BEYOND THE END CAP OF THE FASTCLIX DEVICE. NO ACCIDENTAL STICK OCCURRED. NO ADVERSE EVENT REPORTED. CUSTOMER DID NOT PROVIDE THE LOT NUMBER OF THE DEVICE, NOR THE LANCETS. THE MANUFACTURER REQUESTED RETURN OF SUSPECT PRODUCT FOR EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 290004 | ACCU-CHEK ® FASTCLIX | LANCET DEVICE | FMK | ROCHE DIAGNOSTICS | NA | GRZ008 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | Male |