ELECSYS ESTRADIOL III
Received Jul 9, 2026 · Event occurred Jun 10, 2026
Report 1823260-2026-02786 · MDR key 25768285
Device
Generic name
Radioimmunoassy, Estradiol
Manufacturer
Roche DiagnosticsCatalog number
07027249190
Lot number
88756501
Product problems
- Low Test Results
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS ESTRADIOL III RESULTS FOR 1 PATIENT ON A COBAS E 801 ANALYTICAL UNIT.SAMPLE 1:THE INITIAL AND REPEATED ELECSYS ESTRADIOL RESULTS WERE <5 PG/ML (WITHIN THE POST-MENOPAUSAL REFERENCE RANGE). HOWEVER, THE CORRESPONDING FSH VALUE FOR THIS PATIENT WAS UNEXPECTEDLY LOW. THEREFORE, THE ESTRADIOL RESULTS WERE DETERMINED TO BE LOWER THAN EXPECTED.SAMPLE 2:ON (b)(6) 2026, ANOTHER SAMPLE FROM THE SAME PATIENT WAS TESTED, AND THE RESULT WAS <5 PG/ML. THE SAMPLE WAS SENT TO ANOTHER LABORATORY FOR TESTING USING A SIEMENS SYSTEM, AND THE RESULT WAS 38.9 NG/L (EQUIVALENT TO PG/ML), WHICH ALIGNED WITH THE FOLLICULAR PHASE REFERENCE RANGE (19.0 - 144.2 NG/L) AND CORRELATED WITH THE PATIENT'S FSH LEVEL.
Additional Manufacturer Narrative
THE ANALYZER'S SERIAL NUMBER IS (b)(6).THE INVESTIGATION IS ONGOING.