ELECSYS CORTISOL II
Received Mar 25, 2026 · Event occurred Feb 17, 2026
Report 1823260-2026-01075 · MDR key 24689368
Device
Product problems
- High Test Results
- Low Test Results
- Non Reproducible Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
A REVIEW OF SAMPLE IMAGES FROM THE ANALYZER SHOWED BUBBLES ON THE SAMPLE. THE INVESTIGATION DETERMINED THE ISSUE IS CONSISTENT WITH INSUFFICIENT PRE-ANALYTIC SAMPLE HANDLING.
Additional Manufacturer Narrative
RESULTS FOR OTHER TESTS PERFORMED ON THE SAMPLE HAD FLAGS INDICATING THERE WAS A SAMPLE BUBBLE. CONTROLS WERE WITHIN RANGE AFTER THE EVENT. A REVIEW OF ALARM TRACE DATA SHOWED SAMPLE CLOT DETECTION ALARMS ON THE DAY OF THE EVENT. THE INVESTIGATION IS ONGOING.
Description of Event or Problem
THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ELECSYS TSH V2, ELECSYS CORTISOL II, AND ELECSYS FT4 IV ON A COBAS E 801 ANALYTICAL UNIT. THIS MEDWATCH WILL APPLY TO THE CORTISOL ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE TSH ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE FT4 ASSAY. THE SAMPLE INITIALLY RESULTED IN THE FOLLOWING VALUES: TSH = 0.0171 MIU/L CORTISOL = < 1.50 NMOL/L WITH A DATA FLAG FT4 = < 0.500 PMOL/L WITH A DATA FLAG. THE SAMPLE REPEATED WITH THE FOLLOWING VALUES ON (B)(6) 2026: TSH = 3.23 MIU/L CORTISOL = 527 NMOL/L. FT4 = 16.3 PMOL/L.