FDA Adverse Event
Malfunction
Summary report: N
UNICEL® DXC 600 PRO SYNCHRON® CHEMISTRY ANALYZER
MDR report key: 2013452
·
Received March 10, 2011
Report
- Report Number
- 2050012-2011-00623
- Event Type
- Malfunction
- Date Received
- March 10, 2011
- Date of Event
- February 15, 2011
- Report Date
- February 15, 2011
- Manufacturer
- BECKMAN COULTER INC.
- Product Code
- JGS
- PMA / PMN Number
- K042291
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
QC WAS WITHIN ESTABLISHED RANGES PRIOR TO THE EVENT. A FIELD SERVICE ENGINEER (FSE) WENT ON-SITE AND SAW VISIBLE SIGNS OF CONTAMINATION IN THE FLOWCELL. FSE DECONTAMINATED THE SYSTEM AND VERIFIED PERFORMANCE.
Description of Event or Problem · 1
A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING A FALSE LOW SODIUM (NA) RESULT GENERATED BY THE UNICEL DXC 600 PRO SYNCHRON CHEMISTRY ANALYZER. WHEN THE ANION GAPS WERE LOW, THE LAB RERAN THE SAMPLE ON A DIFFERENT INSTRUMENT AND THOSE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO AFFECT TO PATIENT TREATMENT WITH REGARD TO THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNICEL® DXC 600 PRO SYNCHRON® CHEMISTRY ANALYZER | CLINICAL CHEMISTRY ANALYZER | JGS | BECKMAN COULTER INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |