BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS FSH

    MDR report key: 23866549 · Received December 22, 2025

    Report

    Report Number
    1823260-2025-05288
    Event Type
    Malfunction
    Date Received
    December 22, 2025
    Date of Event
    December 1, 2025
    Report Date
    April 3, 2026
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CGJ
    UDI-DI
    07613336170380
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SAMPLE WAS RECEIVED FOR INVESTIGATION. DURING THE INVESTIGATION, AN INTERFERING FACTOR WAS DETECTED IN THE SAMPLE. THE PRODUCT LABELING STATES: "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." A GENERAL PRODUCT PROBLEM CAN BE EXCLUDED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT WAS DUE TO A KNOWN INTERFERENCE.

    Additional Manufacturer Narrative · 0

    THE FT4 REAGENT LOT NUMBER WAS 89174503 WITH AN EXPIRATION DATE OF 30-SEP-2026. THE FT3 REAGENT LOT NUMBER WAS 84914201 WITH AN EXPIRATION DATE OF 30-APR-2026. THE ANTI-TG REAGENT LOT NUMBER WAS 84585101 WITH AN EXPIRATION DATE OF 31-JAN-2026. THE VITAMIN D TOTAL REAGENT LOT NUMBER WAS 88165901 WITH AN EXPIRATION DATE OF 30-SEP-2026. THE SHBG REAGENT LOT NUMBER WAS 81508501 WITH AN EXPIRATION DATE OF 31-DEC-2025. THE TESTOSTERONE REAGENT LOT NUMBER WAS 83395801 WITH AN EXPIRATION DATE OF 31-MAR-2026. THE CORTISOL REAGENT LOT NUMBER WAS 88552701 WITH AN EXPIRATION DATE OF 31-JUL-2026. THE PROLACTIN REAGENT LOT NUMBER WAS 82669801 WITH AN EXPIRATION DATE OF 31-MAR-2026. THE FSH REAGENT LOT NUMBER WAS 85544702 WITH AN EXPIRATION DATE OF 31-AUG-2026. THE SAMPLE WAS REQUESTED FOR INVESTIGATION. INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT¿S SAMPLE TESTED WITH ELECSYS FT4 IV ASSAY, ELECSYS FT3 III ASSAY, ELECSYS VITAMIN D TOTAL III ASSAY, ELECSYS SHBG ASSAY, ELECSYS TESTOSTERONE II ASSAY, ELECSYS CORTISOL II ASSAY, ELECSYS PROLACTIN II ASSAY, ELECSYS FSH ASSAY, AND ELECSYS ANTI-TG ASSAY ON A COBAS E 801 ANALYTICAL UNIT. THIS MEDWATCH WILL APPLY TO THE FSH ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE VITAMIN D TOTAL III ASSAY, TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE SHBG ASSAY, TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE TESTOSTERONE II ASSAY, TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER(B)(6) FOR INFORMATION RELATED TO THE FT3 III ASSAY, TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE CORTISOL II ASSAY, TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE PROLACTIN II ASSAY, TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE FT4 IV ASSAY, AND TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE ANTI-TG ASSAY. FSH: INITIAL RESULT: <1.00 U/L. REPEAT RESULT: 4.9 U/L. PROLACTIN: INITIAL RESULT: 2.3 G/L. REPEAT RESULT: 4.9 G/L. CORTISOL: INITIAL RESULT: 29.3 G/DL. REPEAT RESULT: 14.9 G/DL. TESTOSTERONE: INITIAL RESULT: 1320 NG/DL. REPEAT RESULT: 361 NG/DL. SHBG: INITIAL RESULT: 13.6 NMOL/L. REPEAT RESULT: 31.3 NMOL/L. VITAMIN D: INITIAL RESULT: 40.5 NMOL/L. REPEAT RESULT: 6 G/L. FT4: INITIAL RESULT: >100 PMOL/L. REPEAT RESULT: 17.7 PMOL/L. FT3: INITIAL RESULT: 13.1 PMOL/L. REPEAT RESULT: 5.61 PMOLL. ANTI-TG: INITIAL RESULT: 2000 KU/L. REPEAT RESULT: <1.30 IU/ML. THE SAMPLE WAS REPEATED ON A SIEMENS ANALYZER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2402208 ELECSYS FSH RADIOIMMUNOASSAY, FOLLICLE-STIMULATING HORMONE CGJ ROCHE DIAGNOSTICS 85544702 07613336170380

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown