FDA Adverse Event
Malfunction
Summary report: N
UNICEL DXI WASH BUFFER
MDR report key: 2200524
·
Received August 11, 2011
Report
- Report Number
- 2122870-2011-02575
- Event Type
- Malfunction
- Date Received
- August 11, 2011
- Date of Event
- July 11, 2011
- Report Date
- July 11, 2011
- Manufacturer
- BECKMAN COULTER INC.
- Product Code
- LDT
- PMA / PMN Number
- EXEMPT
- Removal / Correction Number
- N/A
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- HK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
NO ROOT CAUSE WAS DETERMINED FOR THE LEAKING WITH THE INFORMATION SUPPLIED. SERVICE WAS NOT DISPATCHED FOR THIS EVENT. (B)(4).
Description of Event or Problem · 1
A BECKMAN COULTER, INC. (BEC) HONG KONG PERSONNEL REPORTED RECEIVING ONE (1) DXI WASH BUFFER CUBETAINER THAT WAS LEAKING. A PHOTOGRAPHIC IMAGE OF THE LEAKING CUBETAINER, PROVIDED BY THE CUSTOMER, IS PROVIDED. NO EFFECT TO PATIENTS OR END USERS WAS REPORTED IN CONNECTION WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNICEL DXI WASH BUFFER | GENERAL PURPOSE REAGENT | LDT | BECKMAN COULTER INC. | N/A | 331798F |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |