BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS IGE II IMMUNOASSAY

    MDR report key: 23526047 · Received November 11, 2025

    Report

    Report Number
    1823260-2025-04593
    Event Type
    Malfunction
    Date Received
    November 11, 2025
    Date of Event
    October 22, 2025
    Report Date
    December 30, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JHR
    UDI-DI
    04015630922369
    PMA / PMN Number
    K061970
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE PROVIDED QUALITY CONTROL DATA, A REAGENT ISSUE IS NOT INDICATED. THE AVAILABLE INFORMATION SUGGESTS THE PATIENT SAMPLE EXHIBITS EXTREMELY ELEVATED IGE CONCENTRATIONS > 50000 IU/ML. PER PRODUCT LABELING, THERE IS NO HIGH-DOSE HOOK EFFECT AT IGE CONCENTRATIONS UP TO 50000 IU/ML. THE DILUTED RESULT OF THE SAMPLE MEASURED IN 1:20 DILUTION RESULTED WITH VALUE >50000, WHICH IS ABOVE THE HIGH-DOSE HOOK EFFECT CLAIM. THE INVESTIGATION DETERMINED THE ISSUE IS CONSISTENT WITH A HIGH-DOSE HOOK EFFECT OF THE SAMPLE DUE TO EXTREMELY ELEVATED IGE CONCENTRATIONS.

    Additional Manufacturer Narrative · 0

    THE E601 ANALYZER SERIAL NUMBER IS(B)(6). THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH THE ELECSYS IGE II IMMUNOASSAY ON A COBAS 6000 E601 MODULE. THE SAMPLE INITIALLY RESULTED IN AN IGE VALUE OF 1573 IU/ML. THE SAMPLE WAS DILUTED 1:20 AND REPEATED, RESULTING IN A VALUE OF > 50000 IU/ML WITH A DATA FLAG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2645039 ELECSYS IGE II IMMUNOASSAY RADIOIMMUNOASSAY, IMMUNOGLOBULINS (D,E) JHR ROCHE DIAGNOSTICS 82669002 04015630922369

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown