FDA Adverse Event
Malfunction
Summary report: N
SYNCHRON CX TOTAL PROTEIN REAGENT
MDR report key: 2120605
·
Received June 10, 2011
Report
- Report Number
- 2050012-2011-02137
- Event Type
- Malfunction
- Date Received
- June 10, 2011
- Date of Event
- May 13, 2011
- Report Date
- May 13, 2011
- Manufacturer
- BECKMAN COULTER INC.
- Product Code
- CKA
- PMA / PMN Number
- K883181
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- 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 TOTAL PROTEIN (TP) REAGENT CARTRIDGE WAS LEAKING AND THE CUSTOMER THOUGHT IT APPEARED THAT THE CAPS WERE LOOSE. NO INJURY WAS REPORTED ON THIS ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHRON CX TOTAL PROTEIN REAGENT | TOTAL PROTEIN REAGENT | CKA | BECKMAN COULTER INC. | NA | M103163 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |