BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 C702 MODULE

    MDR report key: 23220601 · Received October 6, 2025

    Report

    Report Number
    1823260-2025-04066
    Event Type
    Malfunction
    Date Received
    October 6, 2025
    Date of Event
    August 26, 2025
    Report Date
    October 6, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K100853
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ALBUMIN REAGENT LOT NUMBER WAS 841293 THE TOTAL PROTEIN REAGENT LOT NUMBER WAS 872539. THE EXPIRATION DATES WERE NOT PROVIDED. THE FIELD SERVICE ENGINEER FOUND HOLES IN THE TUBING ON THE RINSE STATION. HE REPLACED THE TUBING AND CHECKED ALL RINSE STATIONS FOR MOVEMENT. HE CHECKED THE GEAR HEAD PUMP PRESSURE, WASH LEVELS, WASHING OF PROBES, AND PROBE ADJUSTMENTS. NO OTHER ISSUES WERE FOUND. THE INVESTIGATION DETERMINED THAT THE SERVICE ACTIONS RESOLVED THE ISSUE.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE RESULTS FROM THE COBAS 8000 C702 MODULE. PATIENT 1 INITIAL ALBUMIN RESULT WAS 177 G/L, AND THE REPEAT RESULT WAS 25 G/L. PATIENT 2 INITIAL ALBUMIN RESULT WAS 142 G/L, AND THE REPEAT RESULT WAS 36.8 G/L. ON (B)(6) 2025, PATIENT 3 INITIAL TOTAL PROTEIN RESULT WAS 93.9 G/L, AND THE REPEAT RESULT WAS 72 G/L. THE ERRONEOUS RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2716836 COBAS 8000 C702 MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male