ADVIA CENTAUR XP
Received Mar 6, 2012 · Event occurred Jan 23, 2012
Report 2432235-2012-00061 · MDR key 2480690
Device
Generic name
Immunoassay Analyzer
Manufacturer
Siemens Healthcare Diagnostics, Inc.Model number
ADVIA CENTAUR XPCatalog number
078-A010-XX
Lot number
N/A
Product problems
- Incorrect Or Inadequate Test Results
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
POTENTIALLY ERRONEOUS, BUT BELIEVABLE ENHANCED HUMAN IMMUNODEFICIENCY VIRUS (EHIV) PATIENT RESULTS WERE GENERATED ON THE ADVIA CENTAUR XP. IT IS UNKNOWN IF PATIENT RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES OR PATIENT INTERVENTION DUE TO THE POTENTIALLY ERRONEOUS, BUT BELIEVABLE EHIV PATIENT RESULTS.
Additional Manufacturer Narrative
A SIEMENS TECHNICAL SERVICE CONSULTANT (TSC) WAS CONTACTED BY THE CUSTOMER. AFTER EVALUATION OF THE ISSUE AND DATA BY THE TSC, IT WAS DETERMINED THAT THE INSTRUMENT WAS IN FSE (FIELD SERVICE ENGINEER) MODE AND THE CONTROL BRACKETING OPTION HAD BEEN DISABLED. THE OPERATOR RE-ENABLED THE CONTROL BRACKETING OPTION AND LOGGED INTO THE SYSTEM AT THE CUSTOMER LEVEL. THE DEVICE IS PERFORMING WITHIN SPECIFICATION. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.