ADVIA CENTAUR
Received May 29, 2008 · Event occurred Apr 28, 2008
Report 2432235-2008-00058 · MDR key 1054959
Device
Generic name
Immuno-assay Analyzer
Manufacturer
Siemens Healthcare Diagnostics Inc.Model number
NACatalog number
NA
Lot number
NA
Product problems
- Incorrect Or Inadequate Test Results
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
FIVE DISCREPANT RESULTS WERE OBTAINED FOR HCV ON 5 PT SAMPLES. THE SAMPLES WERE REPEATED AND DIFFERENT RESULTS WERE OBTAINED. PT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCREPANT RESULTS.
Additional Manufacturer Narrative
A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER SITE. THE FSE PERFORMED AN INSTRUMENT CERTIFICATION, REPLACED ASPIRATE PROBE 4 WASH GUIDE AND O RINGS, REPLACED ANCILLARY PROBE AND SLEEVE, RECALIBRATED THE ANCILLARY PROBE, REPLACED THE DILUTER, REPLACED LOWER MANIFOLD, AND VALUES, AND REPLACED THE PMT. ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE DISCORDANT WAS DUE TO ONE OR SOME COMBINATION OF THE ACTIONS LISTED ABOVE. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.
Remedial action
- Repair