ADVIA CENTAUR XP
Received May 1, 2014 · Event occurred Mar 26, 2014
Report 2432235-2014-00307 · MDR key 3785310
Device
Generic name
Clinical Chemistry Analyzer
Manufacturer
Siemens Healthcare Diagnostics Inc.Model number
ADVIA CENTAUR XPCatalog number
078-A010-01
Product problems
- Incorrect Or Inadequate Test Results
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
DISCORDANT CARCINOEMBRYONIC ANTIGEN (CEA), FOLATE, TESTOSTERONE (TSTO) AND VITAMIN B12 (VB12) RESULTS WERE OBTAINED ON PATIENT SAMPLES ON AN ADVIA CENTAUR XP INSTRUMENT. THE DISCORDANT RESULTS WERE DISCOVERED AFTER THE CUSTOMER NOTICED THAT QUALITY CONTROLS (QC) WERE OUT OF RANGE. THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE CUSTOMER REPEATED THE SAMPLES SINCE QC WAS LAST IN RANGE AND CORRECTED RESULTS WERE REPORTED TO THE PHYSICIAN(S). IT IS UNKNOWN ON WHAT INSTRUMENT THE SAMPLES WERE REPEATED ON. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT CEA, FOLATE, TSTO AND VB12 RESULTS.
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 DISCOVERED A CLOG IN ASPIRATE PROBE 2. THE CSE UNCLOGGED THE LINE AND PRIMED THE SYSTEM. CALIBRATIONS AND QUALITY CONTROLS WERE RUN, RESULTING WITHIN RANGE. THE CAUSE OF THE DISCORDANT CEA, FOLATE, TSTO AND VB12 RESULTS IS UNKNOWN. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.