FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® MULTICLIX
MDR report key: 3020345
·
Received March 25, 2013
Report
- Report Number
- 1823260-2013-01820
- Event Type
- Malfunction
- Date Received
- March 25, 2013
- Date of Event
- March 5, 2013
- Report Date
- April 17, 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)(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 MULTICLIX DEVICE. NO ACCIDENTAL STICK OCCURRED. NO ADVERSE EVENT REPORTED. CUSTOMER DID NOT PROVIDE THE LOT NUMBER OF THE DEVICE. THE MANUFACTURER REQUESTED RETURN OF SUSPECT PRODUCT FOR EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 121774 | ACCU-CHEK ® MULTICLIX | LANCET DEVICE | FMK | ROCHE DIAGNOSTICS | NA | WPU076 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 056 YR |