UNICEL® DXC 600 PRO SYNCHRON® CHEMISTRY ANALYZER
Received Nov 20, 2010 · Event occurred Oct 22, 2010
Report 2050012-2010-01236 · MDR key 1903791
Device
Generic name
Clinical Chemstry Analyzer
Manufacturer
Beckman Coulter, Inc.Model number
DXC 600 PROCatalog number
A11810
Lot number
NA
Product problems
- Low Test Results
Patient
Not reported
- No Patient Involvement
Narrative
Description of Event or Problem
A CUSTOMER CONTACTED BECKMAN COULTER INC (BCI) IN REGARDS TO ERRONEOUSLY LOW TOTAL PROTEIN RESULTS GENERATED BY UNICEL DXC 600 PRO SYNCHRON CHEMISTRY ANALYZER. THE ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY. THE CUSTOMER NOTICED THE LOW RESULTS AND REPEATED ALL PATIENT SAMPLES SINCE THE LAST GOOD QC ON AN ALTERNATE INSTRUMENT. SEVEN PATIENT RESULTS WERE AMENDED. THE CUSTOMER DOES NOT BELIEVE THAT PATIENTS WERE IMPACTED BY THE ERRONEOUS RESULTS.
Additional Manufacturer Narrative
QC DID NOT DEMONSTRATE AN ISSUE. A BCI FIELD SERVICE ENGINEER (FSE) IDENTIFIED SAMPLE PROBE CARRYOVER, AND REPLACED SAMPLE PROBE AND WASH COLLAR. THE FSE PERFORMED ALIGNMENTS, AND A RETEST PASSED SPECIFICATIONS.
Remedial action
- Inspection
- Replace