BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 C702 MODULE

    MDR report key: 23145142 · Received September 25, 2025

    Report

    Report Number
    1823260-2025-03670
    Event Type
    Malfunction
    Date Received
    September 25, 2025
    Date of Event
    September 4, 2025
    Report Date
    September 25, 2025
    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

    THE CALCIUM REAGENT LOT NUMBER WAS 841368. THE REAGENT EXPIRATION DATE WAS REQUESTED, BUT NOT PROVIDED. THE FIELD SERVICE ENGINEER FOUND PHYSICAL DAMAGE AT A RINSE STATION. TUBING SHOWED NICKS AND WEAR, LIKELY CONTRIBUTING TO WASH INEFFICIENCY AND INCONSISTENT TEST RESULTS. THE AFFECTED TUBING WAS REPLACED AND DETERGENT VOLUMES WERE ADJUSTED. NO FURTHER ISSUES WERE REPORTED AFTER THESE ACTIONS WERE PERFORMED. THE INVESTIGATION DETERMINED THE SERVICE ACTIONS RESOLVED THE ISSUE.

    Description of Event or Problem · 0

    THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH CALCIUM GEN.2 ON A COBAS 8000 C702 MODULE. THE SAMPLE INITIALLY RESULTED IN A CALCIUM VALUE OF 4.67 MG/DL. THE RESULT DID NOT AGREE WITH THE PATIENT'S CLINICAL STATUS AND THE SAMPLE WAS REPEATED. THE REPEAT CALCIUM RESULT WAS 9.22 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2431242 COBAS 8000 C702 MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown