FDA Adverse Event
Malfunction
Summary report: N
GAMMA-GLUTAMYL TRANSFERASE REAGENT
MDR report key: 2381377
·
Received December 19, 2011
Report
- Report Number
- 2050012-2011-08478
- Event Type
- Malfunction
- Date Received
- December 19, 2011
- Date of Event
- November 22, 2011
- Report Date
- November 22, 2011
- Manufacturer
- BECKMAN COULTER, INC.
- Product Code
- JPZ
- PMA / PMN Number
- K971333
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NZ
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
BECKMAN COULTER IDENTIFIER FOR THIS REPORT IS (B)(4).
Description of Event or Problem · 1
ON (B)(6) 2011 CUSTOMER REPORTED THAT THEY RECEIVED TWO CARTRIDGES OF GAMMA-GLUTAMYL TRANSFERASE (GGT) REAGENT THAT WERE LEAKING FROM THE BASE. NO INJURIES OR EXPOSURE WERE REPORTED. BECKMAN COULTER SENT A REPLACEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GAMMA-GLUTAMYL TRANSFERASE REAGENT | COLORIMETRIC METHOD, GAMMA-GLUTAMYL TRANSPEPTIDASE | JPZ | BECKMAN COULTER, INC. | M010446 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |