FDA Adverse Event
Malfunction
Summary report: N
UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER
MDR report key: 1914704
·
Received December 3, 2010
Report
- Report Number
- 2050012-2010-01484
- Event Type
- Malfunction
- Date Received
- December 3, 2010
- Date of Event
- November 1, 2010
- Report Date
- November 4, 2010
- Manufacturer
- BECKMAN COULTER, INC.
- Product Code
- DHR
- PMA / PMN Number
- K042291
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TU
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CALIBRATION AND QC RESULTS WERE ACCEPTABLE. NO SYSTEM ERROR WAS NOTED. THE CUSTOMER IS USING REAGENT LOT M004772. SERVICE WAS NOT NEEDED FOR THIS EVENT, AS THIS ISSUE IS REAGENT RELATED. INVESTIGATION INTO THE ROOT CAUSE OF THIS ISSUE IS ONGOING.
Description of Event or Problem · 1
A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO ERRONEOUSLY POSITIVE RHEUMATOID FACTOR (RF) RESULTS GENERATED BY UNICEL DXC 800 PRO SYNCHRON CHEMISTRY SYSTEM. THE RESULTS WERE REPORTED OUT OF THE LABORATORY, AND WERE QUESTIONED BY PHYSICIAN. NO PATIENT TREATMENT WAS AFFECTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER | CLINICAL CHEMSTRY ANALYZER | DHR | BECKMAN COULTER, INC. | DXC 800 PRO | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |