BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS FSH

    MDR report key: 23096281 · Received September 19, 2025

    Report

    Report Number
    1823260-2025-03186
    Event Type
    Malfunction
    Date Received
    September 19, 2025
    Date of Event
    August 18, 2025
    Report Date
    November 7, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CGJ
    UDI-DI
    07613336170373
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE AFP REAGENT LOT NUMBER WAS 821474. THE EXPIRATION DATE WAS NOT PROVIDED. THE COBAS E411 DISK SERIAL NUMBER WAS (B)(6). THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    THE SAMPLE FOR PATIENT 2 WAS REPEATED FOR A 2ND TIME FOR FSH ON (B)(6) 2025, AND THE 2ND REPEAT RESULT WAS 4.5 MIU/ML. NO CALIBRATION INFLUENCE WAS OBSERVED. THE PROVIDED QC WAS NOT WITHIN EXPECTATIONS FOR THE DAY OF THE EVENT. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED WITH ELECSYS AFP ASSAY AND 1 PATIENT SAMPLE TESTED WITH ELECSYS FSH ASSAY ON A COBAS E411 IMMUNOASSAY ANALYZER (DISK SYSTEM). THIS MEDWATCH WILL APPLY TO THE FSH ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE AFP ASSAY. PATIENT 1: AFP: INITIAL RESULT: 0.750 IU/ML (ACCOMPANIED BY A DATA FLAG). REPEAT RESULT: 51.95 IU/ML. PATIENT 2 WAS TESTED ON (B)(6) 2025: FSH: INITIAL RESULT: 0.300 MIU/ML. REPEAT RESULT: 6.20 MIU/ML.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1764774 ELECSYS FSH RADIOIMMUNOASSAY, FOLLICLE-STIMULATING HORMONE CGJ ROCHE DIAGNOSTICS 813861 07613336170373

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown