FDA Adverse Event
Malfunction
Summary report: N
CX/LX LIPASE (LIP)
MDR report key: 2120608
·
Received June 10, 2011
Report
- Report Number
- 2050012-2011-02133
- Event Type
- Malfunction
- Date Received
- June 10, 2011
- Date of Event
- May 17, 2011
- Report Date
- May 17, 2011
- Manufacturer
- BECKMAN COULTER INC.
- Product Code
- CHI
- PMA / PMN Number
- CL. I EXEMPT
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
REPLACEMENT REAGENT WAS SENT.
Description of Event or Problem · 1
A CUSTOMER CONTACTED BECKMAN COULTER INC., (BCI) AND REPORTED THAT THEY RECEIVED LIPASE (LIP) REAGENT SHIPMENT AND THERE WAS A LEAKAGE ON TOP OF THE LIPASE (LIP) CARTRIDGE. NO INJURY WAS REPORTED ON THIS ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CX/LX LIPASE (LIP) | LIPASE (LIP) | CHI | BECKMAN COULTER INC. | NA | M103004 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |