BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 C702 MODULE

    MDR report key: 24306018 · Received February 10, 2026

    Report

    Report Number
    1823260-2026-00457
    Event Type
    Malfunction
    Date Received
    February 10, 2026
    Date of Event
    January 20, 2026
    Report Date
    March 18, 2026
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K100853
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    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.

    Additional Manufacturer Narrative · 0

    THE FIELD SERVICE ENGINEER (FSE) FOUND A HOLE IN A VACUUM TUBE OF THE RINSE UNIT. THE FSE REPLACED THE TUBING, CHECKED THE RINSE LEVELS, AND PERFORMED PRECISION TESTING WITH ACCEPTABLE RESULTS. 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 HIGH RESULTS FOR 2 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 11.7 MG/DL. THE CUSTOMER HAS A RULE IN THE SYSTEM TO FLAG POTENTIAL INCORRECT RESULTS. THE SAMPLE WAS REPEATED WITH A RESULT OF 9.5 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116638 COBAS 8000 C702 MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown