BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 C702 MODULE

    MDR report key: 24489345 · Received March 2, 2026

    Report

    Report Number
    1823260-2026-00748
    Event Type
    Malfunction
    Date Received
    March 2, 2026
    Date of Event
    February 9, 2026
    Report Date
    March 25, 2026
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K100853
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REAGENT LOT NUMBER IS 911238. THE EXPIRATION DATE WAS NOT PROVIDED. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    THE FIELD SERVICE ENGINEER INSPECTED THE MODULE AND PERFORMED MULTIPLE TROUBLESHOOTING ACTIONS AND REPAIRS, INCLUDING A SOLENOID VALVE REPLACEMENT. THE FAULTY SOLENOID VALVE CAUSED AN INCORRECT CELL CLEANING. THE INVESTIGATION DETERMINED THAT THE FAULTY SOLENOID VALVE CAUSED THE EVENT. THE CUSTOMER HAS NOT REPORTED ANY OTHER ISSUES AFTER THE SERVICE. THE INVESTIGATION DETERMINED THAT THE SERVICE ACTIONS RESOLVED THE ISSUE.

    Description of Event or Problem · 0

    THE INITIAL REPORTER RECEIVED A QUESTIONABLE UREA/BUN ASSAY RESULT FROM ONE PATIENT SAMPLE TESTED ON THE COBAS 8000 C702 MODULE. THE INITIAL RESULT WAS 1.1 MMOL/L. THE REPEAT RESULT WAS 18.4 MMOL/L. THE QUESTIONABLE RESULT WAS NOT REPORTED OUTSIDE THE LABORATORY. THE REPEAT RESULT WAS DEEMED CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    540763 COBAS 8000 C702 MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown