BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS IGE II

    MDR report key: 21876330 · Received April 21, 2025

    Report

    Report Number
    1823260-2025-01211
    Event Type
    Malfunction
    Date Received
    April 21, 2025
    Date of Event
    March 30, 2025
    Report Date
    April 30, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JHR
    PMA / PMN Number
    K061970
    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 SERIAL NUMBER OF THE E 801 ANALYZER IS (B)(6). THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    NO CALIBRATION INFLUENCE WAS OBSERVED. QUALITY CONTROLS WERE WITHIN RANGE. A GENERAL REAGENT ISSUE CAN BE EXCLUDED. ISOLATED NON-REPRODUCIBLE RESULTS DO NOT REPRESENT A GENERAL MALFUNCTION OF THE ASSAY. A REVIEW OF ALARM TRACE DATA SHOWED NO ABNORMALITIES AROUND THE TIME OF THE EVENT. A FEW SAMPLES QUALITY RELATED ALARMS WERE OBSERVED. THE INVESTIGATION COULD NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ELECSYS IGE II ON A COBAS E 801 ANALYTICAL UNIT. THE SAMPLE INITIALLY RESULTED IN AN IGE VALUE OF 7.75 IU/ML. THE SAMPLE WAS REPEATED ON A SECOND ANALYZER ON (B)(6) 2025, RESULTING IN AN IGE VALUE OF 1037 IU/ML. THE SAMPLE WAS REPEATED ON THE ORIGINAL ANALYZER ON (B)(6) 2025, RESULTING IN AN IGE VALUE OF 1038 IU/ML.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1239073 ELECSYS IGE II RADIOIMMUNOASSAY, IMMUNOGLOBULINS (D, E) JHR ROCHE DIAGNOSTICS 826681

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown