D
Patient 1
A CUSTOMER CONTACTED BECKMAN COULTER INC., (BCI) AND REPORTED THAT A LOOSE CAP ON THE AMMONIA REAGENT CARTRIDGE CAUSED A LEAK. NO INJURY WAS REPORTED ON THIS ISSUE.
MAUDE MDR 2114832
- MDR report key
- 2114832
- Report number
- 2050012-2011-02151
- Event key
- 0
- Event type
- 3
- Date of event
- 2011-02-28
- Date received
- 2011-06-06
- 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 BLVD. 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 | CX AMMONIA REAGENT | AMMONIA REAGENT | BECKMAN COULTER INC. | JIF | NA | 439770 | UNKNOWN | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2011-06-06 | 0 |
Event Narratives#
N
Patient 1
REPLACEMENT REAGENT WAS SENT.