FDA Adverse Event
Malfunction
Summary report: N
UNICEL® DXI 800 ACCESS® IMMUNOASSAY ANALYZER
MDR report key: 1984328
·
Received February 10, 2011
Report
- Report Number
- 2122870-2011-00257
- 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
- JJE
- PMA / PMN Number
- K023764
- Removal / Correction Number
- NA
- 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 A REACTIVE RUBELLA IGM RESULT GENERATED BY UNICEL DXI 800 ACCESS IMMUNOASSAY ANALYZER FOR ONE PATIENT. THE RESULT WAS REPORTED OUT OF THE LABORATORY, AND WAS DISCORDANT TO ANOTHER METHODOLOGY. IT IS UNKNOWN IF PATIENT TREATMENT WAS IMPACTED BY THIS EVENT. THE EVENT OCCURRED SOMETIME BETWEEN (B)(6) 2010 AND (B)(6) 2010.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNICEL® DXI 800 ACCESS® IMMUNOASSAY ANALYZER | DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER | JJE | BECKMAN COULTER, INC. | DXI 800 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 42 YR |