FDA Adverse Event
Malfunction
Summary report: N
SYNCHRON CX SYSTEMS URIC ACID (URIC) REAGENT
MDR report key: 2282684
·
Received October 7, 2011
Report
- Report Number
- 2050012-2011-06037
- Event Type
- Malfunction
- Date Received
- October 7, 2011
- Date of Event
- September 14, 2011
- Report Date
- September 14, 2011
- Manufacturer
- BECKMAN COULTER, INC.
- Product Code
- KNK
- PMA / PMN Number
- K970919
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NZ
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CARTRIDGE WAS CRACKED. (B)(4).
Description of Event or Problem · 1
ON (B)(6) 2011, CUSTOMER REPORTED THAT THEY RECEIVED A BROKEN CARTRIDGE OF URIC ACID. NO EXPOSURE OR INJURIES WERE REPORTED. SINCE IT IS UNCLEAR WHICH COMPARTMENT OF THE CARTRIDGE LEAKED, AND IN THE EVENT IT WAS COMPARTMENT B, WHICH CONTAINS MATERIALS OF ANIMAL ORIGIN AND UPON RECUR IT COULD POTENTIALLY EXPOSE PERSONS TO INFECTIOUS DISEASES, IT WAS DECIDED THAT AN MDR SHOULD BE FILED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHRON CX SYSTEMS URIC ACID (URIC) REAGENT | ACID, URIC, URICASE (COLORIMETRIC) | KNK | BECKMAN COULTER, INC. | M104187 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |