BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 C702 MODULE

    MDR report key: 24380135 · Received February 18, 2026

    Report

    Report Number
    1823260-2026-00581
    Event Type
    Malfunction
    Date Received
    February 18, 2026
    Date of Event
    January 27, 2026
    Report Date
    February 18, 2026
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K100853
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E1: INITIAL REPORTER TELEPHONE NUMBER WAS (B)(6). THE REAGENT LOT NUMBER WAS 911238. THE EXPIRATION DATE WAS NOT PROVIDED. THE FIELD SERVICE ENGINEER CHECKED THE ANALYZER AND PERFORMED VARIOUS CHECKS AND TROUBLESHOOTING ACTIONS, BUT HE DID NOT FIND ANY ISSUES. THE INVESTIGATION WAS UNABLE TO DETERMINE A SPECIFIC ROOT CAUSE. THE ISSUE APPEARED TO BE RESOLVED AFTER THE SERVICE ACTIONS.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE UREA RESULTS FROM THE COBAS 8000 C702 MODULE. OF THE DATA PROVIDED, ONLY ONE EXAMPLE WAS A REPORTABLE MALFUNCTION. THE INITIAL RESULT WAS <0.5 MMOL/L. THE CLINICIAN REQUESTED REPEAT TESTING, AND THE RESULT WAS 9.4 MMOL/L.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    438595 COBAS 8000 C702 MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown