BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS ESTRADIOL III

    MDR report key: 25072946 · Received May 4, 2026

    Report

    Report Number
    1823260-2026-01730
    Event Type
    Malfunction
    Date Received
    May 4, 2026
    Date of Event
    April 9, 2026
    Report Date
    May 29, 2026
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CHP
    UDI-DI
    04015630939671
    PMA / PMN Number
    K965109
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE EXPIRATION DATES OF BOTH LOT NUMBERS FOR THE ESTRADIOL III REAGENT WERE NOT PROVIDED. THE COBAS E 801 ANALYTICAL UNIT SERIAL NUMBER WAS (B)(6). THE QC WAS ACCEPTABLE. THE FIELD SERVICE ENGINEER (FSE) REPLACED THE PINCH VALVES, REAGENT PROBES, AND PINCH TUBING AND CLEANED THE SAMPLING AREA. HE THEN VERIFIED CORRECT SYSTEM WATER PRESSURE, THE WASH STATIONS' DISCHARGE WATER AND THE DRAIN, THE PROBES, AND THE BEAD MIXER. AN INSTRUMENT CHECK, CALIBRATION, AND QC WERE PERFORMED, AND THEY WERE WITHIN SPECIFICATIONS. THE DATA WAS REVIEWED. THE MAINTENANCE WAS UP TO DATE, AND THE ALARM TRACE DID NOT SHOW ANY SPECIFIC ISSUES. THE CUSTOMER WAS RUNNING ALL SAMPLES TESTED FOR ESTRADIOL III IN DUPLICATE UNTIL THE ISSUE WAS RESOLVED. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    THE ESTRADIOL III REAGENT LOT 88756500 HAS AN EXPIRATION DATE OF 31-AUG-2026. THE CUSTOMER ALLEGED DISCREPANT ESTRADIOL III RESULTS FOR AN ADDITIONAL 3 PATIENTS' SAMPLES: SAMPLE 6 WAS TESTED ON 20-MAY-2026: INITIAL RESULT: 8323 PMOL/L. REPEAT RESULT: 1174 PMOL/L (TESTED ON A COMPETITOR'S ANALYZER). SAMPLE 7 AND SAMPLE 8 WERE TESTED ON 22-MAY-2026: SAMPLE 7: INITIAL RESULT: 176 PMOL/L. REPEAT RESULT: 57 PMOL/L (TESTED ON A COMPETITOR'S ANALYZER). THIS RESULT WAS DEEMED TO BE CORRECT. SAMPLE 8: INITIAL RESULT: 630 PMOL/L. THIS RESULT WAS DEEMED TO BE CORRECT. REPEAT RESULT: 1973 PMOL/L (TESTED ON A COMPETITOR'S ANALYZER). THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 2 PATIENTS' SAMPLES TESTED WITH ELECSYS ESTRADIOL III ASSAY ON A COBAS E 801 ANALYTICAL UNIT. SAMPLE 1 WAS TESTED USING THE REAGENT LOT NUMBER 88756500: INITIAL RESULT: 155 PMOL/L. 1ST REPEAT RESULT: 271 PMOL/L. ON (B)(6) 2026: 2ND REPEAT RESULT: 166 PMOL/L. SAMPLE 2 WAS TESTED USING THE REAGENT LOT NUMBER 931204: ON (B)(6) 2026: INITIAL RESULT: <18.4 PMOL/L. 1ST REPEAT RESULT: 198 PMOL/L. ON (B)(6) 2026: 2ND REPEAT RESULT: 291 PMOL/L. 3RD REPEAT RESULT: <18.4 PMOL/L. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE THE LABORATORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431049 ELECSYS ESTRADIOL III RADIOIMMUNOASSY, ESTRADIOL CHP ROCHE DIAGNOSTICS 88756500, 931204 04015630939671

    Patients

    Seq Age Sex Outcome Treatment
    1