ELECSYS CORTISOL II
Received Jun 22, 2026 · Event occurred May 27, 2026
Report 1823260-2026-02458 · MDR key 25575734
Device
Generic name
Fluorometric, Cortisol
Manufacturer
Roche DiagnosticsCatalog number
06687733190
Lot number
922327
Product problems
- High Test Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE EXPIRATION DATE FOR THE ELECSYS CORTISOL II REAGENT WAS NOT PROVIDED. THE COBAS E 411 ANALYZER (DISK SYSTEM) SERIAL NUMBER WAS (B)(6). THE PATIENT SAMPLE IS NOT AVAILABLE FOR INVESTIGATION. THE CALIBRATION WAS PERFORMED ON (B)(6) 2026, AND THEY WERE ACCEPTABLE. THE QC WAS WITHIN THE RANGES. THE ALARM TRACE SHOWED 2 "LIQUID FLOW CLEANING (LFC) IS RECOMMENDED" ALARMS AND 2 SAMPLE PIPETTING ALARMS ON (B)(6) 2026. THE INVESTIGATION IS ONGOING.
Description of Event or Problem
WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED WITH ELECSYS CORTISOL II ASSAY ON A COBAS E 411 ANALYZER (DISK SYSTEM). THE INITIAL RESULT WAS >1750 NMOL/L (ACCOMPANIED BY A DATA FLAG). THE 1ST REPEAT RESULT WAS >1750 NMOL/L. THE SAMPLE WAS THEN SENT TO A DIFFERENT LABORATORY, AND ON (B)(6) 2026, THE 2ND REPEAT RESULT WAS 291 NMOL/L. THE REPEAT RESULT OF 291 NMOL/L WAS CONSIDERED "NORMAL". AN INTERFERENT IS SUSPECTED IN THE PATIENT SAMPLE.