FDA Adverse Event
Malfunction
Summary report: N
SYNCHRON LX SYSTEMS HIGH SENSITIVITY C-REACTIVE PROTIEN (CRPH) REAGENT
MDR report key: 2152810
·
Received July 7, 2011
Report
- Report Number
- 2050012-2011-02697
- Event Type
- Malfunction
- Date Received
- July 7, 2011
- Date of Event
- June 7, 2011
- Report Date
- June 7, 2011
- Manufacturer
- BECKMAN COULTER INC.
- Product Code
- DCK
- PMA / PMN Number
- K010597
- Removal / Correction Number
- N/A
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
NO ADDITIONAL INFORMATION IS AVAILABLE.
Description of Event or Problem · 1
A BECKMAN COULTER INC (BEC) (B)(4) REPORTED RECEIVING C-REACTIVE PROTEIN (CRP) CARTRIDGE WHICH HAD LEAKED THOUGH THE CAP. PERSONAL PROTECTIVE EQUIPMENT WAS USED WHEN HANDLING THE CARTRIDGE. NO INJURY OR EXPOSURES WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHRON LX SYSTEMS HIGH SENSITIVITY C-REACTIVE PROTIEN (CRPH) REAGENT | C-REACTIVE PROTEIN IMMUNOLOGICAL TEST SYSTEM | DCK | BECKMAN COULTER INC. | N/A | M012386 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |