FDA Adverse Event
Malfunction
Summary report: N
UNICEL® DXI 800 ACCESS® IMMUNOASSAY SYSTEM
MDR report key: 1983774
·
Received February 10, 2011
Report
- Report Number
- 2122870-2011-00317
- Event Type
- Malfunction
- Date Received
- February 10, 2011
- Date of Event
- September 1, 2010
- Report Date
- January 13, 2011
- Manufacturer
- BECKMAN COULTER INC.
- Product Code
- LGD
- PMA / PMN Number
- K023764
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
QC AND SYSTEM INFORMATION ARE NOT AVAILABLE. SAMPLE COLLECTION AND CENTRIFUGATION INFORMATION HAS NOT BEEN PROVIDED. SERVICE WAS NOT DISPATCHED. A CLEAR ROOT CAUSE CAN NOT BE DETERMINED FOR THIS EVENT BASED ON THE INFORMATION PROVIDED.
Description of Event or Problem · 1
A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI), TO REPORT OBTAINING REACTIVE TOXO IGM RESULT ON ONE (1) PATIENT WHICH WAS DISCORDANT TO ANOTHER METHODOLOGY. THE RESULT WAS REPORTED OUT OF THE LABORATORY. UNKNOWN IF PATIENT TREATMENT WAS IMPACTED BY THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNICEL® DXI 800 ACCESS® IMMUNOASSAY SYSTEM | DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER | LGD | BECKMAN COULTER INC. | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 36 YR |