ELECSYS CORTISOL II
Received Dec 15, 2025 · Event occurred Oct 29, 2025
Report 1823260-2025-05122 · MDR key 23810641
Device
Generic name
Fluorometric, Cortisol
Manufacturer
Roche DiagnosticsCatalog number
07027150190
Lot number
885527
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Low Test Results
- Non Reproducible Results
- Incorrect, Inadequate or Imprecise Result or Readings
- Low Test Results
- Non Reproducible Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE ANALYZER SERIAL NUMBER IS (B)(6). THE INVESTIGATION IS ONGOING.
Description of Event or Problem
THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS CORTISOL III RESULTS FOR 2 SAMPLES FROM THE SAME PATIENT ON A COBAS PURE E 402 ANALYTICAL UNIT. THE CUSTOMER QUESTIONED THE INITIAL LOW RESULTS WHICH PROMPTED THEM TO REPEAT THE PATIENT SAMPLES. SAMPLE 1 HAD AN INITIAL RESULT OF 26.2 NMOL/L. THE FIRST REPEAT RESULT WAS >1750 NMOL/L. A 1:10 DILUTION WAS PERFORMED ON THE SAMPLE AND THE RESULT WAS >17500 NMOL/L. A 1:100 DILUTION WAS PERFORMED ON THE SAMPLE AND THE RESULT WAS 20272 NMOL/L WITH FLAG. SAMPLE 2 HAD AN INITIAL RESULT OF 28.3 NMOL/L. THE REPEAT RESULT WAS 566 NMOL/L.
Additional Manufacturer Narrative
THE QC RECOVERY DATA PROVIDED WAS WITHIN SPECIFICATION. BASED ON THE QC DATA, A GENERAL REAGENT ISSUE COULD BE EXCLUDED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED.