ADVIA CENTAUR XP
Received Apr 25, 2013 · Event occurred Mar 27, 2013
Report 2432235-2013-00152 · MDR key 3079113
Device
Generic name
Immunoassay Analyzer
Manufacturer
Siemens Healthcare Diagnostics Inc.Model number
ADVIA CENTAUR XPCatalog number
078-A010
Product problems
- False Negative Result
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
A DISCORDANT (B)(6) RESULT FOR (B)(6) WAS OBTAINED ON AN ADVIA CENTAUR XP INSTRUMENT. IT IS NOT KNOWN IF THE DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN. THE LABORATORY RERAN THE SAME SAMPLE ON THE SAME INSTRUMENT AND THE RESULT WAS (B)(6). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE (B)(6) RESULT.
Additional Manufacturer Narrative
A SIEMENS FIELD SERVICE ENGINEER WAS DISPATCHED TO THE CUSTOMER SITE. THE FSE ANALYZED THE INSTRUMENT AND DETERMINED THE CAUSE OF THE DISCORDANT (B)(6) RESULT WAS UNKNOWN. THE FSE ADJUSTED AND ALIGNED THE SAMPLE PROBE. THE FSE ALSO PERFORMED PREVENTIVE MAINTENANCE AND THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. FURTHER EVALUATION OF THE DEVICE IS NOT REQUIRED.