ELECSYS FSH
Received Apr 22, 2026 · Event occurred Mar 31, 2026
Report 1823260-2026-01547 · MDR key 24956933
Device
Generic name
Radioimmunoassay, Follicle-stimulating Hormone
Manufacturer
Roche DiagnosticsCatalog number
08932352190
Lot number
871044
Product problems
- Incorrect Measurement
- Low Test Results
- Non Reproducible Results
Patient
34 YR · Female
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE COBAS E411 DISK SERIAL NUMBER WAS (B)(6). THE FIELD SERVICE ENGINEER FOUND THAT THE BEAD MIXTURE WAS CREATING BUBBLES IN THE MICROBEADS COMPARTMENT IN THE REAGENT. HE REPLACED THE BEAD MIXTURE SHAFT AND ADJUSTED THE MIXER SPEED. THE INVESTIGATION IS ONGOING.
Description of Event or Problem
THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS FSH RESULTS FROM THE COBAS E411 DISK ANALYZER. PATIENT 1 INITIAL RESULT WAS < 0.300 MIU/ML WITH A DATA FLAG, AND THE REPEAT RESULT WAS 36.25 MIU/ML. PATIENT 2 INITIAL RESULT WAS < 0.300 MIU/ML WITH A DATA FLAG, AND THE REPEAT RESULT WAS 7.5 MIU/ML.
Additional Manufacturer Narrative
THE INVESTIGATION DETERMIEND THAT THE SERVICE ACTIONS RESOLVED THE ISSUE.