FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® MULTICLIX
MDR report key: 3092470
·
Received May 3, 2013
Report
- Report Number
- 1823260-2013-02745
- Event Type
- Malfunction
- Date Received
- May 3, 2013
- Date of Event
- February 9, 2013
- Report Date
- June 6, 2013
- 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
Narratives
Additional Manufacturer Narrative · 1
THE EVENT OCCURRED IN (B)(4). 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
CALLER REPORTS LANCET PROTRUDES BEYOND THE END CAP OF THE MULTICLIX DEVICE. CALLER STATES THE PATIENT COMPLAINED THAT THE FINGER STICK HURT AND QUITE A BIT OF BLOOD WAS FLOWING AFTER USE. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 193684 | ACCU-CHEK ® MULTICLIX | LANCET DEVICE | FMK | ROCHE DIAGNOSTICS | NA | WPX216 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 007 YR |