FDA Adverse Event
Malfunction
Summary report: N
CX/LX GGT KIT
MDR report key: 2055115
·
Received April 14, 2011
Report
- Report Number
- 2050012-2011-00914
- Event Type
- Malfunction
- Date Received
- April 14, 2011
- Date of Event
- March 11, 2011
- Report Date
- March 14, 2011
- Manufacturer
- BECKMAN COULTER INC.
- Product Code
- JQB
- PMA / PMN Number
- EXEMPT
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
REPLACEMENT WAS SENT TO THE CUSTOMER.
Description of Event or Problem · 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CX/LX GGT KIT | GGT KIT | JQB | BECKMAN COULTER INC. | NA | M006732 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |