FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® MULTICLIX
MDR report key: 2083451
·
Received May 10, 2011
Report
- Report Number
- 1823260-2011-02500
- Event Type
- Malfunction
- Date Received
- May 10, 2011
- Date of Event
- April 4, 2011
- Report Date
- July 28, 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
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
THE EVENT OCCURRED IN (B)(4).
Description of Event or Problem · 1
CALLER REPORTS LANCET PROTRUDES BEYOND THE END CAP OF THE MULTICLIX DEVICE. NO ACCIDENTAL NEEDLE STICK OCCURRED. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACCU-CHEK ® MULTICLIX | LANCET DEVICE | FMK | ROCHE DIAGNOSTICS | NA | WPW071 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 068 YR | DIOVAN| ASAPHEN| METFORMIN 3 TIMES DAILY| "LIBURID" TWICE DAILY |