IMMULITE 2000
Received Nov 12, 2014 · Event occurred Oct 16, 2014
Report 2247117-2014-00072 · MDR key 4246138
Device
Generic name
Immulite 2000
Manufacturer
Siemens Healthcare Diagnostics Inc.Model number
IMMULITE 2000Catalog number
30002
Product problems
- Low Test Results
Patient
76 YR
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
A DISCORDANT, FALSELY LOW CARCINOEMBRYONIC ANTIGEN (CEA) RESULT WAS OBTAINED ON ONE PATIENT SAMPLE ON AN IMMULITE 2000 INSTRUMENT. THE FALSELY LOW CEA RESULT WAS REPORTED TO THE PHYSICIAN(S) AND QUESTIONED. THE SAME SAMPLE WAS REPEATED ON THE SAME INSTRUMENT AND RESULTED HIGHER THAN THE INITIAL RESULT. A NEW SAMPLE WAS DRAWN AND RUN ON AN ALTERNATE PLATFORM WHICH ALSO RESULTED HIGHER THAN THE INITIAL RESULT. THE CORRECTED RESULT WAS REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY LOW CEA RESULT.
Additional Manufacturer Narrative
A SIEMENS HEADQUARTERS SUPPORT CENTER (HSC) SPECIALIST REVIEWED INSTRUMENT DATA. THE HSC OBSERVED THAT THE ADJUSTMENTS WERE WITHIN ACCEPTABLE RANGE, BUT THERE WERE NO QUALITY CONTROL (QC) SAMPLES RUN AFTER ADJUSTMENT. THE HSC ALSO NOTICED THAT TWO OF THREE QC SAMPLES WERE OUT OF RANGE ON THE DAY DISCORDANT RESULT WAS OBTAINED. THE CAUSE OF DISCORDANT CEA RESULT IS UNKNOWN.