FDA Adverse Event
Malfunction
Summary report: N
SYNCHRON SYSTEMS C-REACTIVE PROTEIN (C-RP) CALIBRATOR
MDR report key: 2383192
·
Received December 20, 2011
Report
- Report Number
- 2050012-2011-08455
- Event Type
- Malfunction
- Date Received
- December 20, 2011
- Date of Event
- November 18, 2011
- Report Date
- November 18, 2011
- Manufacturer
- BECKMAN COULTER INC.
- Product Code
- JIS
- PMA / PMN Number
- K021572
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INVENTORY HAS BEEN TRANSFERRED TO QUARANTINE SUB-INVENTORY. NO ADDITIONAL INFORMATION IS AVAILABLE. (B)(4).
Description of Event or Problem · 1
BECKMAN COULTER EUROCENTER IN ITALY REPORTED THAT THEY RECEIVED CX/LX C-RP CAL KIT BOTTLES LEAKING DUE TO LOOSE CAPS. NO INJURY WAS REPORTED DUE TO THE EXPOSURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHRON SYSTEMS C-REACTIVE PROTEIN (C-RP) CALIBRATOR | C-REACTIVE PROTEIN (C-RP) CALIBRATOR | JIS | BECKMAN COULTER INC. | NA | M101480 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |