MalfunctionCDX
ADVIA CENTAUR FT4
Received Nov 18, 2011 · Event occurred Oct 17, 2011
Report 1219913-2011-00178 · MDR key 2341709
Device
Generic name
Ft4
Manufacturer
Siemens Healthcare Diagnostics, Inc.Model number
N/ACatalog number
08074354
Lot number
UNKNOWN
Product problems
- High Test Results
Patient
31 YR
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
ELEVATED ADVIA CENTAUR FT4 RESULTS WERE OBTAINED FOR A PATIENT SAMPLES. THE RESULTS WERE DISCORDANT WITH AN ALTERNATE METHOD. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT FT4 RESULT.
Additional Manufacturer Narrative
THE CAUSE FOR THE DISCORDANT FT4 RESULT IS UNKNOWN. THE QUALITY CONTROL AND CALIBRATION WERE WITHIN ACCEPTABLE RANGE. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATION. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.
Remedial action
- Inspection