BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 400 PLUS

    MDR report key: 23233456 · Received October 7, 2025

    Report

    Report Number
    1823260-2025-04088
    Event Type
    Malfunction
    Date Received
    October 7, 2025
    Date of Event
    September 15, 2025
    Report Date
    November 7, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K951595
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D, DEVICE IDENTIFICATION WAS UPDATED. RELEVANT FIELDS OF SECTIONS D AND G WERE UPDATED. THE INVESTIGATION DETERMINED THAT THE ROOT CAUSE IS RELATED TO A HARDWARE ISSUE (PROBES). THE INVESTIGATION DETERMINED THAT THE CUSTOMER'S ACTIONS (CHANGING THE PROBES) RESOLVED THE ISSUE.

    Additional Manufacturer Narrative · 0

    THE COBAS INTEGRA 400 PLUS SERIAL NUMBER IS (B)(6). IT WAS REPORTED THAT THE CALIBRATION FOR THE NEW CASSETTE (862109) FAILED AND REOCCURRED ANOTHER TIME. THE CUSTOMER CHANGED THE PROBES, AND THAT APPEARS TO HAVE RESOLVED THE PROBLEM. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE HOMOCYSTEINE ENZYMATIC ASSAY RESULTS FROM THE COBAS INTEGRA 400 PLUS FOR ONE PATIENT. THE SAMPLE WAS FIRST MEASURED FOUR TIMES USING ONE CASSETTE. THE FIRST RESULT WAS 34.7 MOL/L. THE SECOND RESULT WAS 20.8 MOL/L. THE THIRD RESULT WAS 33.1 MOL/L. THE FOURTH RESULT WAS 21.4 MOL/L. THE SAMPLE WAS THEN MEASURED TWO MORE TIMES USING A NEW CASSETTE. THE FIRST RESULT WITH THE NEW CASSETTE WAS 33.4 MOL/L. THE SECOND RESULT WITH THE NEW CASSETTE WAS 23.8 MOL/L.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1487071 COBAS INTEGRA 400 PLUS CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS 819829/862109

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown