FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® SOFTCLIX
MDR report key: 2143134
·
Received June 28, 2011
Report
- Report Number
- 1823260-2011-03496
- Event Type
- Malfunction
- Date Received
- June 28, 2011
- Date of Event
- June 27, 2011
- Report Date
- August 30, 2011
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- FMK
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
THE EVENT OCCURRED IN (B)(6).
Description of Event or Problem · 1
CALLER REPORTS LANCET PROTRUDES BEYOND THE END CAP OF THE SOFTCLIX DEVICE. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE DEVICE AND LANCETS, REPLACEMENT WAS SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACCU-CHEK ® SOFTCLIX | LANCET DEVICE | FMK | ROCHE DIAGNOSTICS | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 055 YR |