D
Patient 1
A CUSTOMER CONTACTED BECKMAN COULTER INC., (BCI) STATING THAT THEY RECEIVED LEAKING CX/LX GAMMA-GLUTAMYL TRANSPEPTIDASE (GGT) REAGENT DUE TO LOOSE CAP. NO INJURY WAS REPORTED ON THIS ISSUE.
MAUDE MDR 2055115
- MDR report key
- 2055115
- Report number
- 2050012-2011-00914
- Event key
- 0
- Event type
- 3
- Date of event
- 2011-03-11
- Date received
- 2011-04-14
- 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/LX GGT KIT | GGT KIT | BECKMAN COULTER INC. | JQB | NA | 476846 | M006732 | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2011-04-14 | 0 |
Event Narratives#
N
Patient 1
REPLACEMENT WAS SENT TO THE CUSTOMER.