FDA Adverse Event
Malfunction
Summary report: N
SYNCHRON CX(TM)5 CLINICAL ANALYZER
MDR report key: 2173968
·
Received July 24, 2011
Report
- Report Number
- 2050012-2011-02989
- Event Type
- Malfunction
- Date Received
- July 24, 2011
- Date of Event
- June 22, 2011
- Report Date
- June 22, 2011
- Manufacturer
- BECKMAN COULTER INC
- Product Code
- JJE
- PMA / PMN Number
- K881495
- Removal / Correction Number
- N/A
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE SAMPLES WERE SERUM. PER CUSTOMER, THE QC WAS WITHIN THE LABORATORY ESTABLISHED RANGES PRIOR TO AND AFTER THE EVENT. A BCI FIELD SERVICE ENGINEER (FSE) CLEANED THE FLOW-CELL AND REPLACED THE CARBON BRIDGE. FSE VERIFIED PERFORMANCE.
Description of Event or Problem · 1
A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) IN REGARDS ERRONEOUS HIGH SODIUM (NA) RESULTS ON 4 PATIENT SAMPLES GENERATED BY SYNCHRON CX5 DELTA CLINICAL SYSTEM. THE RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. THE SAMPLES WERE REPEATED AND LOWER RESULTS WERE OBTAINED. PATIENT TREATMENT WAS NOT IMPACTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHRON CX(TM)5 CLINICAL ANALYZER | DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER FOR CLINICAL USE. | JJE | BECKMAN COULTER INC | CX 5 DELTA | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |