ADVIA CENTAUR CP
Received Jul 10, 2009 · Event occurred Jun 29, 2009
Report 2432235-2009-00139 · MDR key 1473312
Device
Generic name
Immuno-assay Analyzer
Manufacturer
Siemens Healthcare Diagnostics Inc.Model number
ADVIA CENTAUR CPCatalog number
086-A001-01
Lot number
NA
Product problems
- Low Test Results
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
DISCORDANT ADVIA CENTAUR CP MYOGLOBIN RESULTS WERE OBTAINED ON PATIENT SAMPLES. THE RESULTS WERE REPORTED TO THE PHYSICIAN. UPON RETEST, THE CORRECTED RESULTS WERE REPORTED TO THE PHYSICIAN. THERE WAS NO REPORT OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT MYOGLOBIN RESULTS.
Additional Manufacturer Narrative
A SIEMENS HEALTHCARE FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER SITE. ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE DISCORDANT MYOGLOBIN RESULTS WAS DUE TO THE MALFUNCTION OF THE SAMPLE DILUTER AND THE SAMPLE SYRINGE. THE INSTRUMENT WAS REPAIRED. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.
Remedial action
- Repair