BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS IGF-1

    MDR report key: 23450187 · Received November 3, 2025

    Report

    Report Number
    1823260-2025-04457
    Event Type
    Malfunction
    Date Received
    November 3, 2025
    Date of Event
    September 30, 2025
    Report Date
    December 9, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CFL
    UDI-DI
    07613336140864
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ROCHE AND SIEMENS METHODS ARE NOT COMPARABLE. INTERNAL INVESTIGATIONS DETERMINED A CALIBRATION ISSUE WITH THE ELECSYS IGF-1 ASSAY, LEADING TO ELEVATED RESULTS IN PATIENT SAMPLES WITH VERY HIGH IGF-1 CONCENTRATIONS (BETWEEN 800 NG/ML AND 1600 NG/ML). DILUTED RESULTS MORE ACCURATELY REFLECT THE TRUE IGF-1 CONCENTRATION. THERE WAS NO ISSUE WITH IGF-1 RESULTS <800 NG/ML. THE CALIBRATION ISSUE WAS CORRECTED, AND CUSTOMERS WERE ADVISED TO CHANGE TO THE NEW LOT NUMBERS 912807 AND 912815. HOWEVER, EVEN WITH THE NEW LOT NUMBERS, THE ROCHE RESULTS WOULD REMAIN DIFFERENT FROM THE SIEMENS RESULTS AS THE METHODS ARE NOT COMPARABLE.

    Additional Manufacturer Narrative · 0

    THE E801 MODULE SERIAL NUMBER WAS (B)(6).

    Description of Event or Problem · 0

    THE INITIAL REPORTER COMPLAINED OF HIGH RESULTS FOR MULTIPLE PATIENT SAMPLES TESTED FOR ELECSYS IGF-1 (IGF-1) STARTING AT THE BEGINNING OF (B)(6) 2025 ON A COBAS 8000 E 801 MODULE. THE CUSTOMER HAD PREVIOUSLY USED THE IMMULITE INSTRUMENT, AND THE IGF-1 RESULTS WERE LOWER. AN EXAMPLE OF QUESTIONABLE RESULTS WAS PROVIDED FOR 1 PATIENT SAMPLE. ON (B)(6) 2025, THE RESULT FROM THE SIEMENS METHOD WAS 706.0 NG/ML. ON (B)(6) 2025, THE RESULT FROM THE E801 MODULE WAS 1107 NG/ML. THE REPEAT RESULT WAS 1153 NG/ML. THE PATIENT HAD A PREVIOUS RESULT (B)(6) 2025) FROM THE IMMULITE INSTRUMENT OF 673 NG/ML.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1798192 ELECSYS IGF-1 RADIOIMMUNOASSAY, HUMAN GROWTH HORMONE CFL ROCHE DIAGNOSTICS 853644 07613336140864

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Male