MalfunctionCDX
ADVIA CENTAUR XP FT4
Received Nov 30, 2011 · Event occurred Sep 14, 2011
Report 1219913-2011-00179 · MDR key 2352498
Device
Generic name
Ft4
Manufacturer
Siemens Healthcare Diagnostics, Inc.Model number
N/ACatalog number
08074354
Lot number
028
Product problems
- Incorrect Or Inadequate Test Results
Patient
83 YR
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
ELEVATED ADVIA CENTAUR XP FT4 RESULTS WERE OBTAINED FOR SAMPLES FROM ONE PATIENT. 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 RESULTS 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