FDA Adverse Event
Malfunction
Summary report: N
UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEM
MDR report key: 1914672
·
Received December 3, 2010
Report
- Report Number
- 2050012-2010-01482
- Event Type
- Malfunction
- Date Received
- December 3, 2010
- Date of Event
- November 4, 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
- FR
- 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 THE ISSUE IS RELATED TO REAGENT. INVESTIGATION INTO ROOT CAUSE OF THIS EVENT IS ONGOING.
Description of Event or Problem · 1
A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO (B)(6) RHEUMATOID FACTOR (RF) RESULTS GENERATED BY UNICEL DXC 600 SYNCHRON CLINICAL SYSTEM. THE CUSTOMER INDICATED THE RESULTS ARE BETWEEN 20 AND 30 IU/ML, WHEN THEY SHOULD BE < 20 IU/ML. THE RESULTS WERE REPORTED OUT OF THE LABORATORY. THERE WAS NO EFFECT TO PATIENT TREATMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEM | CLINICAL CHEMSTRY ANALYZER | DHR | BECKMAN COULTER, INC. | DXC 600 PRO | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |