D
Patient 1
A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) TO REPORT A LIQUID LEAK OF THE LX PRO HIGH SENSITIVITY CRP REAGENT. INCIDENT OCCURRED AT BCI WAREHOUSE. NO INJURY WAS REPORTED FOR THIS EVENT.
MAUDE MDR 2066336
- MDR report key
- 2066336
- Report number
- 2050012-2011-01230
- Event key
- 0
- Event type
- 3
- Date of event
- 2011-03-22
- Date received
- 2011-04-21
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 0
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Contact
- MS. NORA ZEROUNIAN
- Address
- 250 S KRAEMER BOULEVARD BREA CA 92821 US
- Phone
- 714-714-7149
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | LX PRO HIGH SENSITIVITY CRP | LX PRO HIGH SENSITIVITY CRP | BECKMAN COULTER INC. | NQD | N/A | 378020 | MO12386 | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2011-04-21 | 0 |
Event Narratives#
N
Patient 1
THERE WAS NO LOOSENING OF THE CAP. THE LIQUID ADHERED TO THE BOTTLE. A CLEAR ROOT CAUSE IS UNKNOWN AT THIS TIME.