BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 COBAS C 701 MODULE

    MDR report key: 24239330 · Received February 2, 2026

    Report

    Report Number
    1823260-2026-00353
    Event Type
    Malfunction
    Date Received
    February 2, 2026
    Date of Event
    January 9, 2026
    Report Date
    March 4, 2026
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K100853
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SERVICE MAINTENANCE ACTIONS PERFORMED BY THE FSE RESOLVED THE ISSUE.

    Additional Manufacturer Narrative · 0

    THE REAGENT LOT NUMBER IS 911238. THE EXPIRATION DATE WAS NOT PROVIDED. THE FIELD SERVICE ENGINEER (FSE) FOUND THAT THE GEAR PUMP PRESSURE WAS LOW, RESIDUES ON THE INCUBATION WATER BATH, CUVETTES, AND ULTRASONIC MIXERS, AND WORN TEFLON TIPS. THE FSE REMEDIED THE ISSUES IDENTIFIED. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE UREA/BUN RESULTS FOR 1 PATIENT SAMPLE ON A COBAS 8000 COBAS C 701 MODULE. THE INITIAL RESULT WAS 102.7 MG/DL. THE DOCTOR QUESTIONED THE RESULT WHICH PROMPTED THE CUSTOMER TO REPEAT THE SAMPLE. THE REPEAT RESULT WAS 24.6 MG/DL. THE REPEAT RESULT WAS DEEMED CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292144 COBAS 8000 COBAS C 701 MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown