BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS FSH

    MDR report key: 22506720 · Received July 15, 2025

    Report

    Report Number
    1823260-2025-02147
    Event Type
    Malfunction
    Date Received
    July 15, 2025
    Date of Event
    June 20, 2025
    Report Date
    August 29, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CGJ
    UDI-DI
    04015630909223
    PMA / PMN Number
    K964693
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPETITOR METHOD WAS (B)(4). THE E601 MODULE SERIAL NUMBER WAS (B)(6). THE SAMPLE WAS REQUESTED FOR INVESTIGATION.

    Additional Manufacturer Narrative · 0

    CALIBRATION AND QC WERE ACCEPTABLE. THE SAMPLE WAS RECEIVED FOR INVESTIGATION. UPON FURTHER INVESTIGATION OF THE PATIENT SAMPLE, AN INTERFERENT AGAINST THE STREPTAVIDIN COMPONENT OF THE REAGENT WAS CONFIRMED. THIS INTERFERENCE IS COVERED IN PRODUCT LABELING: "IN RARE CASES, INTERFERENCE DUE TO EXTREMELY HIGH TITERS OF ANTIBODIES TO ANALYTE-SPECIFIC ANTIBODIES, STREPTAVIDIN OR RUTHENIUM CAN OCCUR. THESE EFFECTS ARE MINIMIZED BY SUITABLE TEST DESIGN. FOR DIAGNOSTIC PURPOSES, THE RESULTS SHOULD ALWAYS BE ASSESSED IN CONJUNCTION WITH THE PATIENT¿S MEDICAL HISTORY, CLINICAL EXAMINATION AND OTHER FINDINGS." THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.

    Description of Event or Problem · 0

    WE RECEIVED AN ALLEGATION OF DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS ESTRADIOL III ASSAY (ESTRADIOL III) AND ELECSYS FSH (FSH) ON A COBAS 6000 E601 MODULE. THE ESTRADIOL III RESULT FROM THE E601 MODULE WAS 769.20 PMOL/L. THE SAMPLE WAS REPEATED TWICE ON THE E601 MODULE WITH RESULTS OF 800.8 PMOL/L AND 804.6 PMOL/L. THE FSH RESULT FROM THE E601 MODULE WAS 1.31 IU/L. THE DOCTOR QUESTIONED THE ESTRADIOL RESULT AS IT WAS NOT CONSISTENT WITH THE PATIENT¿S CONDITION. THE SAMPLE WAS REPEATED BY A COMPETITOR METHOD, AND THE ESTRADIOL RESULT WAS < 55.1 PMOL/, L AND THE FSH RESULT WAS 1.85 MIU/ML. THIS MEDWATCH WILL COVER FSH. REFER TO MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE ESTRADIOL III RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1770675 ELECSYS FSH RADIOIMMUNOASSAY, FOLLICLE-STIMULATING HORMONE CGJ ROCHE DIAGNOSTICS ASKU 04015630909223

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Female