FDA Adverse Event
Malfunction
Summary report: N
UNICEL® DXC 800 SYNCHRON® CLINICAL SYSTEM
MDR report key: 2173455
·
Received July 23, 2011
Report
- Report Number
- 2050012-2011-03344
- Event Type
- Malfunction
- Date Received
- July 23, 2011
- Date of Event
- June 22, 2011
- Report Date
- June 22, 2011
- Manufacturer
- BECKMAN COULTER INC.
- Product Code
- JJE
- 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
PER THE CUSTOMER, QC HAD BEEN WITHIN LAB-ESTABLISHED RANGES. A FIELD SERVICE ENGINEER (FSE) DECONTAMINATED THE INSTRUMENT AND VERIFIED PERFORMANCE.
Description of Event or Problem · 1
A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) AND REPORTED THAT THE UNICEL DXC 800 SYNCHRON CLINICAL SYSTEM WAS GENERATING LOW ANION GAPS. THE DATA PROVIDED SHOWED THAT HIGHER CARBON DIOXIDE (CO2) RESULTS CAUSED THE ISSUE. WHEN SAMPLES WERE REPEATED ON THE OTHER INSTRUMENT IN THE LAB, THE CO2 RESULTS WERE LOWER AND THOSE RESULTS WERE REPORTED. NO WRONG RESULTS WERE REPORTED OUT OF THE LAB. THERE WAS NO EFFECT TO PATIENT TREATMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNICEL® DXC 800 SYNCHRON® CLINICAL SYSTEM | CLINICAL CHEMISTRY ANALYZER | JJE | BECKMAN COULTER INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 80 YR |