FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® MULTICLIX LANCETS
MDR report key: 3192963
·
Received June 27, 2013
Report
- Report Number
- 1823260-2013-03913
- Event Type
- Malfunction
- Date Received
- June 27, 2013
- Date of Event
- June 2, 2013
- Report Date
- September 24, 2013
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- FMK
- PMA / PMN Number
- EXEMPT
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
THE EVENT OCCURRED IN (B)(6).
Description of Event or Problem · 1
REPORTER STATED LANCET PROTRUDES BEYOND THE END CAP OF THE MULTICLIX DEVICE. NO ACCIDENTAL STICK OCCURRED. THE CUSTOMER INDICATED THE LANCET STICK WAS PAINFUL. NO MEDICAL TREATMENT RECEIVED. 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 |
|---|---|---|---|---|---|---|---|
| 293882 | ACCU-CHEK ® MULTICLIX LANCETS | LANCET | FMK | ROCHE DIAGNOSTICS | NA | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 030 YR |