ADVIA CENTAUR
Received Oct 29, 2014 · Event occurred Oct 4, 2014
Report 2432235-2014-00625 · MDR key 4212192
Device
Generic name
Immunoassay Analyzer
Manufacturer
Siemens Healthcare Diagnostics, Inc.Model number
ADVIA CENTAURCatalog number
078-A001-08
Product problems
- Incorrect Or Inadequate Test Results
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS DISPATCHED TO THE CUSTOMER SITE. AFTER EVALUATION OF THE INSTRUMENT AND INSTRUMENT DATA, THE CSE REPLACED THE DISPENSE DILUTER 1 ASSEMBLY. THE CSE ALSO PERFORMED AN INSTRUMENT SERVICE CHECK. THE CAUSE OF THE DISCORDANT (B)(6) RESULTS IS UNKNOWN. THE CSE SUCCESSFULLY RAN A DISPENSE TEST AND QUALITY CONTROLS. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. FURTHER EVALUATION OF THE DEVICE IS NOT REQUIRED.
Description of Event or Problem
(B)(6) RESULTS WERE OBTAINED ON MULTIPLE PATIENT SAMPLES ON AN ADVIA CENTAUR INSTRUMENT. THE INITIAL RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE REPEATED ON THE SAME SYSTEM. IT IS UNKNOWN AS TO WHICH REPEAT (B)(6) RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES OR PATIENT INTERVENTION DUE TO THE DISCORDANT (B)(6) RESULTS.