ELECSYS FSH
Received Jun 11, 2026 · Event occurred May 4, 2026
Report 1823260-2026-02303 · MDR key 25469925
Device
Generic name
Radioimmunoassay, Follicle-stimulating Hormone
Manufacturer
Roche DiagnosticsCatalog number
08932352190
Lot number
87104400
Product problems
- Incorrect Measurement
- High Test Results
- Non Reproducible Results
Patient
34 YR · Female
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE COBAS E 411 IMMUNOASSAY ANALYZER SERIAL NUMBER WAS (B)(6). THE QC WAS ACCEPTABLE. THE FIELD SERVICE ENGINEER (FSE) INSPECTED THE INSTRUMENT THOROUGHLY AND CHECKED AND CLEANED THE SAMPLE PROBE. HE ALSO CHECKED THE REAGENT PROBE AND THE MIXER. THE FSE THEN DID A PERFORMANCE TESTING WITH SUCCESSFUL RESULTS. PRECISION STUDIES WERE PERFORMED, AND THEY WERE WITHIN SPECIFICATIONS. THE INVESTIGATION IS ONGOING.
Description of Event or Problem
WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED WITH ELECSYS FSH ASSAY ON A COBAS E 411 IMMUNOASSAY ANALYZER, AND NOT ALIGNING WITH THE PATIENT'S CLINICAL PICTURE AND PREVIOUS TEST RESULTS. THE INITIAL RESULT WAS 51 MIU/ML. THE CUSTOMER QUESTIONED THE INITIAL RESULT AND REPEATED THE SAMPLE. THE 1ST AND 2ND REPEAT RESULTS WERE BOTH OF THE SAME VALUE AS THE INITIAL RESULT. ON (B)(6) 2026, A NEW SAMPLE WAS DRAWN AND TESTED. THE RESULT WAS 12 MIU/ML, AND WAS ALIGNED WITH THE PATIENT'S EXPECTED CLINICAL PICTURE.