FDA Adverse Event
Malfunction
Summary report: N
SYNCHRON® SYSTEMS GAMMA-GLUTAMYL TRANSFERASE (GGT) REAGENT
MDR report key: 2233744
·
Received September 3, 2011
Report
- Report Number
- 2050012-2011-04767
- Event Type
- Malfunction
- Date Received
- September 3, 2011
- Date of Event
- July 26, 2011
- Report Date
- August 5, 2011
- Manufacturer
- BECKMAN COULTER INC.
- Product Code
- JIX
- PMA / PMN Number
- K971333
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE CUSTOMER WAS SENT A REPLACEMENT. (B)(4).
Description of Event or Problem · 1
THE CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) REPORTING THAT THE SYNCHRON SYSTEMS GAMMA-GLUTAMYL TRANSFERASE (GGT) REAGENT WAS LEAKING FROM THE BOTTOM OF THE CARTRIDGE. THE CUSTOMER INDICATED THAT THE CARTRIDGE WAS NOT WELL SEALED. NO INJURY OR OPERATOR EXPOSURE WAS REPORTED FOR THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHRON® SYSTEMS GAMMA-GLUTAMYL TRANSFERASE (GGT) REAGENT | KINETIC METHOD, GAMMA-GLUTAMYL TRANSPEPTIDASE | JIX | BECKMAN COULTER INC. | N/A | T011111 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |