UNICEL® DXC 800 SYNCHRON® CHEMISTRY ANALYZER
Received Apr 26, 2010 · Event occurred Apr 3, 2010
Report 2050012-2010-00215 · MDR key 1667112
Device
Generic name
Clinical Chemistry Analyzer
Manufacturer
Beckman Coulter Inc.Model number
NACatalog number
A11816
Lot number
NA
Product problems
- Low Test Results
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING A LOW PHOSPHOROUS (PHOS) RESULT GENERATED BY THE UNICEL DXC 800 SYNCHRON CHEMISTRY ANALYZER. THE ORIGINAL PHOS RESULT WAS SUPPRESSED OIR LO (OUT OF INSTRUMENT RANGE) AND THE RESULT ON A DIFFERENT INSTRUMENT WAS 3.54 MG/DL. THIS RESULT WAS REPORTED OUT OF THE LABORATORY. THERE WAS NO IMPACT TO PATIENT TREATMENT AS A RESULT OF THIS EVENT.
Additional Manufacturer Narrative
THE SAMPLE WAS SERUM. QC WAS IN RANGE BEFORE THE EVENT. HOTLINE HELPED CUSTOMER TROUBLESHOOT THE ISSUE AND DISCOVERED THE PHOS LAMP HAD FAILED. THE CUSTOMER REPLACED THE LAMP AND THE SYSTEM STARTED OPERATING ACCEPTABLY. A MALFUNCTION WILL BE ASSUMED FOR THE PURPOSE OF THIS REPORT.
Remedial action
- Other