BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 400 PLUS

    MDR report key: 23008844 · Received September 9, 2025

    Report

    Report Number
    1823260-2025-02803
    Event Type
    Malfunction
    Date Received
    September 9, 2025
    Date of Event
    August 20, 2025
    Report Date
    October 31, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K951595
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDWATCH FIELDS D1-D4, G1, AND G4 WERE UPDATED. THE INVESTIGATION WAS UNABLE TO DETERMINE A SPECIFIC ROOT CAUSE BASED ON THE LIMITED INFORMATION, AND BECAUSE THE ANALYZER WAS NON-OPERATIONAL DUE TO AN INTERNAL LAB PROBLEM AT THE CUSTOMER SITE. INFORMATION WAS PROVIDED THAT THE SITE HAD AN INTERNAL WATER QUALITY ISSUE.

    Additional Manufacturer Narrative · 0

    THE COBAS INTEGRA 400 PLUS SERIAL NUMBER WAS (B)(6). THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF CALIBRATION AND QC ISSUES AND QUESTIONABLE IRON GEN.2 RESULTS FROM THE COBAS INTEGRA 400 PLUS. THE INITIAL RESULT WAS 7.5 MOL/L. THE REPEAT RESULT WAS 13.5 MOL/L.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2827631 COBAS INTEGRA 400 PLUS CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown