BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 C702 MODULE

    MDR report key: 23659507 · Received November 26, 2025

    Report

    Report Number
    1823260-2025-04886
    Event Type
    Malfunction
    Date Received
    November 26, 2025
    Date of Event
    November 11, 2025
    Report Date
    November 26, 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 CA2 REAGENT LOT NUMBER WAS 882078 WITH AN EXPIRATION DATE OF 31-AUG-2026. REAGENT ISSUES WERE EXCLUDED AS THE CUSTOMER HAD NO FURTHER ISSUES, AND THE CORRECT REPEAT RESULT WAS RECEIVED USING THE SAME REAGENT. THE FIELD SERVICE ENGINEER (FSE) FOUND LEAKY CELL RINSE TUBES; THE TUBES WERE REPAIRED, AND THE MODULE WAS OPERATING WITHIN SPECIFICATION. THE INVESTIGATION DETERMINED THAT THE ISSUE FOUND BY THE FSE WAS THE ROOT CAUSE OF THE EVENT.

    Description of Event or Problem · 0

    THE INITIAL REPORTER QUESTIONED LOW RESULTS FOR AN UNSPECIFIED NUMBER OF PATIENT SAMPLES TESTED FOR CALCIUM GEN.2 (CA2) ON A COBAS 8000 C702 MODULE. AN EXAMPLE OF DISCREPANT RESULTS WAS PROVIDED FOR 1 PATIENT SAMPLE. THE INITIAL RESULT WAS 4 MG/DL. THE REPEAT RESULT ON A DIFFERENT MODULE WAS 8 MG/DL. THE REPEAT RESULT WAS BELIEVED TO BE CORRECT BASED ON THE PATIENT¿S HISTORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2538638 COBAS 8000 C702 MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown