FDA Adverse Event
Malfunction
Summary report: N
CX/LX DBIL KIT
MDR report key: 2132953
·
Received June 17, 2011
Report
- Report Number
- 2050012-2011-02282
- Event Type
- Malfunction
- Date Received
- June 17, 2011
- Date of Event
- May 13, 2011
- Report Date
- May 18, 2011
- Manufacturer
- BECKMAN COULTER INC.
- Product Code
- JFM
- PMA / PMN Number
- K053090
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
NO ADDITIONAL INFORMATION IS AVAILABLE.
Additional Manufacturer Narrative · 1
THIS FOLLOW-UP REPORT IS TO PROVIDE AN EXPIRATION DATE FOR THE DBIL REAGENT.
Description of Event or Problem · 1
CUSTOMER CONTACTED BECKMAN COULTER INC., (BCI) AND REPORTED THAT THE DBIL CARTRIDGE WAS LEAKING FROM THE BOTTOM SEAM. NO INJURY WAS REPORTED ON THIS ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CX/LX DBIL KIT | DIRECT BILIRUBIN REAGENT | JFM | BECKMAN COULTER INC. | NA | Z010037 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |