FDA Adverse Event
Malfunction
Summary report: N
SYNCHRON® SYSTEMS C-REACTVE PROTEIN (C-RP) REAGENT
MDR report key: 2519210
·
Received April 5, 2012
Report
- Report Number
- 2050012-2012-00892
- Event Type
- Malfunction
- Date Received
- April 5, 2012
- Date of Event
- March 23, 2012
- Report Date
- March 23, 2012
- Manufacturer
- BECKMAN COULTER INC.
- Product Code
- DCK
- PMA / PMN Number
- K974050
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- EZ
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE CUSTOMER REPORTED NOTICING A RUPTURE ON THE NECK OF COMPARTMENT B OF A SYNCHRON SYSTEMS C-REACTVE PROTEIN (C-RP) REAGENT. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT CONSISTING OF A LAB COAT, GLOVES AND DIOPTRIC GLASSES DURING THE EVENT AND THERE WAS NO INJURY REPORTED DUE TO THE EXPOSURE. THE VOLUME OF THE LEAK WAS REPORTED TO BE ABOUT 50 UL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHRON® SYSTEMS C-REACTVE PROTEIN (C-RP) REAGENT | C-REACTIVE PROTEIN, ANTIGEN, ANTISERUM, AND CONTROL | DCK | BECKMAN COULTER INC. | N/A | M108003 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |