ADVIA CENTAUR XP FT4
Received Dec 8, 2011 · Event occurred Nov 7, 2011
Report 1219913-2011-00182 · MDR key 2363478
Device
Generic name
Ft4
Manufacturer
Siemens Healthcare Diagnostics, Inc.Model number
N/ACatalog number
08074354
Lot number
032
Product problems
- Low Test Results
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
A FALSE LOW ADVIA CENTAUR XP FT4 RESULT WAS OBTAINED FOR A PATIENT SAMPLE. THE RESULT WAS QUESTIONED. REPEAT TESTING WAS PERFORMED ON THE OTHER ADVIA CENTAUR XP AND AN ALTERNATE METHOD. THE RESULTS WERE HIGHER. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT FT4 RESULT.
Additional Manufacturer Narrative
A SIEMENS FIELD SERVICE ENGINEER (FSE ) WAS SENT TO THE CUSTOMER SITE FOR SYSTEM INSPECTION. THE FSE PERFORMED PREVENTATIVE MAINTENANCE AND ADJUSTED REAGENT PROBE 1. THE FSE PERFORMED A PRECISION RUN USING PREVIOUS DISCREPANT PATIENT SAMPLE. THE VALUES FOR THE PATIENT SAMPLE WERE SIMILAR TO THE RESULTS OBTAINED ON THE OTHER ADVIA CENTAUR XP AND THE ALTERNATE METHOD. NO CONCLUSION CAN BE DRAWN. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATION. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.
Remedial action
- Inspection