ATELLICA CH A-LYTE INTEGRATED MULTISENSOR (IMT NA K CL)
Received Jun 19, 2026 · Event occurred May 24, 2026
Report 2432235-2026-00145 · MDR key 25563007
Device
Generic name
Electrode, Ion Specific, Sodium
Manufacturer
Siemens Healthcare Diagnostics Inc.Model number
N/ACatalog number
11099315
Lot number
150012
Product problems
- High Test Results
Patient
10 DA · Male
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
AN OUTSIDE UNITED STATES (OUS) CUSTOMER CONTACTED SIEMENS HEALTHCARE DIAGNOSTICS REGARDING ERRONEOUSLY ELEVATED SODIUM PATIENT SAMPLE RESULTS FOR ONE (1) PATIENT. SIEMENS HEALTHCARE DIAGNOSTICS IS INVESTIGATING THE EVENT.
Description of Event or Problem
THE CUSTOMER REPORTED TO SIEMENS FOUR (4) ERRONEOUSLY ELEVATED SODIUM RESULTS WERE OBTAINED FOR ONE PATIENT SAMPLE ON AN ATELLICA CH 930 ANALYZER. ONE OF THE FOUR RESULTS WAS REPORTED TO THE PHYSICIAN(S) AND WAS QUESTIONED. THE SAMPLE WAS REPROCESSED FOR SODIUM ON A NON-SIEMENS ANALYZER, RECOVERING LOWER. THE LOWER SODIUM RESULT WAS CONSIDERED TO BE THE CORRECT RESULT. THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO ERRONEOUSLY ELEVATED SODIUM RESULTS.