FDA Adverse Event
Malfunction
Summary report: N
SYNCHRON® LX 20 PRO CLINICAL SYSTEMS
MDR report key: 2083752
·
Received May 10, 2011
Report
- Report Number
- 2050012-2011-01596
- Event Type
- Malfunction
- Date Received
- May 10, 2011
- Date of Event
- April 11, 2011
- Report Date
- April 11, 2011
- Manufacturer
- BECKMAN COULTER INC.
- Product Code
- JJE
- PMA / PMN Number
- K011213
- Removal / Correction Number
- N/A
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ME, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
SAMPLE COLLECTION WERE NOT PROVIDED. QC RECOVERED WITHIN LAB-ESTABLISHED RANGES. IF QC WAS NOT RUN AFTER STANDBY, THE INSTRUMENT WOULD NOT EXHIBIT THE ISSUE. BCI FIELD SERVICE ENGINEER (FDS) REPLACED THE RATIO PUMP AND VERIFIED PERFORMANCE.
Description of Event or Problem · 1
A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) TO REPORT THAT THE SYNCHRON LX20 ANALYZER GENERATED SODIUM RESULTS APPROXIMATELY 5MMOL/L HIGHER THAN SUBSEQUENT RESULTS. REPEATED TESTING GENERATED LOWER RESULTS AND WERE REPORTED. THERE WAS NO EFFECT ON PATIENTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHRON® LX 20 PRO CLINICAL SYSTEMS | CLINICAL CHEMISTRY ANALYZER | JJE | BECKMAN COULTER INC. | LX 20 PRO | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |