ADVIA CENTAUR XP
Received Oct 27, 2012 · Event occurred Oct 1, 2012
Report 2432235-2012-00361 · MDR key 2807106
Device
Generic name
Immunoassay Analyzer
Manufacturer
Siemens Healthcare Diagnostics Inc.Model number
ADVIA CENTAUR XPCatalog number
078-A010-XX
Lot number
233
Product problems
- False Negative Result
Patient
80 YR
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
A (B)(6) RESULT FOR ANTIBODIES TO (B)(6) WAS OBTAINED ON AN ADVIA CENTAUR XP INSTRUMENT. THE PATIENT WAS KNOWN OF BEING (B)(6). THE INITIAL RESULT WAS NOT REPORTED OUT. THE SAME SAMPLE WAS RERUN ON THE SAME INSTRUMENT AND A POSITIVE RESULT WAS OBTAINED. THE REPEATED RESULT WAS REPORTED TO THE PHYSICIAN(S). 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 (FSE) WAS DISPATCHED TO THE CUSTOMER SITE. THE FSE ANALYZED THE INSTRUMENT. THE CAUSE OF THE SINGLE (B)(6) IS UNKNOWN. THE FSE VERIFIED THE CALIBRATION AND THE QUALITY CONTROL. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. FURTHER EVALUATION OF THE DEVICE IS NOT REQUIRED.