FDA Adverse Event
Malfunction
Summary report: N
UNICEL® DXC 600 PRO SYNCHRON® CHEMISTRY ANALYZER
MDR report key: 1693327
·
Received May 18, 2010
Report
- Report Number
- 2050012-2010-00272
- Event Type
- Malfunction
- Date Received
- May 18, 2010
- Date of Event
- May 5, 2010
- Report Date
- May 18, 2010
- Manufacturer
- BECKMAN COULTER INC.
- Product Code
- JGS
- PMA / PMN Number
- K042291
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE SYSTEM IS CALIBRATED THREE TIMES A DAY AND QC RESULTS WERE WITHIN THE LAB'S ESTABLISHED RANGES PRIOR TO THE EVENT. A BCI ENGINEER CLEANED THE FLOW CELL. NO FURTHER ISSUES HAVE BEEN REPORTED TO DATE. A CLEAR ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED TO DATE.
Description of Event or Problem · 1
CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING ERRONEOUSLY LOW SODIUM (NA) RESULTS GENERATED BY THE UNICEL DXC 600 PRO SYNCHRON CHEMISTRY ANALYZER. THE ORIGINAL NA RESULTS WERE IN THE RANGE 117-134 MMOL/L AND THEY REPEATED IN THE RANGE 124-141 MMOL/L. THE ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. NO REPORTS OF DEATH, INJURY OR CHANGE TO PATIENT TREATMENT HAVE BEEN REPORTED IN CONNECTION WITH 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 |