FDA Adverse Event
Malfunction
Summary report: N
SOFTCLIX ® LANCET DEVICE
MDR report key: 3173526
·
Received June 17, 2013
Report
- Report Number
- 1823260-2013-03650
- Event Type
- Malfunction
- Date Received
- June 17, 2013
- Date of Event
- April 15, 2013
- Report Date
- June 26, 2013
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- FMK
- PMA / PMN Number
- EXEMPT
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
THE EVENT OCCURRED IN (B)(6).
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.
Description of Event or Problem · 1
REPORTER STATED LANCET PROTRUDES BEYOND THE END CAP OF THE SOFTCLIX 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 |
|---|---|---|---|---|---|---|---|
| 273604 | SOFTCLIX ® LANCET DEVICE | LANCET DEVICE | FMK | ROCHE DIAGNOSTICS | NA | BAT004 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 078 YR |