BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UREA/BUN

    MDR report key: 23293546 · Received October 15, 2025

    Report

    Report Number
    1823260-2025-04189
    Event Type
    Malfunction
    Date Received
    October 15, 2025
    Date of Event
    September 21, 2025
    Report Date
    November 21, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CDQ
    UDI-DI
    04015630925131
    PMA / PMN Number
    K972250
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE C702 MODULE SERIAL NUMBER WAS (B)(6). THE FIELD SERVICE ENGINEER (FSE) PERFORMED INSTRUMENT DECONTAMINATION, AND THE ISSUE WAS RESOLVED. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION DETERMINED THAT THE SERVICE ACTIONS RESOLVED THE ISSUE.

    Description of Event or Problem · 0

    THE INITIAL REPORTER COMPLAINED OF DISCREPANT LOW RESULTS FOR 2 PATIENT SAMPLES TESTED FOR UREA/BUN ON A COBAS 8000 C702 MODULE. PATIENT 1 INITIAL RESULT WAS 3.6 MG/DL. ON (B)(6) 2025, THE REPEAT RESULT WAS 13.2 MG/DL. PATIENT 2 INITIAL RESULT WAS 1.4 MG/DL. ON (B)(6) 2025, THE REPEAT RESULT WAS 34.7 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2535897 UREA/BUN UREA NITROGEN TEST SYSTEM CDQ ROCHE DIAGNOSTICS 867715 04015630925131

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown