BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 C702 MODULE

    MDR report key: 22356779 · Received June 30, 2025

    Report

    Report Number
    1823260-2025-01976
    Event Type
    Malfunction
    Date Received
    June 30, 2025
    Date of Event
    June 6, 2025
    Report Date
    July 21, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K100853
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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) CHECKED THE INSTRUMENT AND REPLACED THE DIAPHRAGM VALVES AND THE SAMPLE PROBES. BASED ON THE INFORMATION PROVIDED, THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    THE CHOL2 REAGENT LOT NUMBER WAS 839947 WITH AN EXPIRATION DATE OF 31-AUG-2025. THE GLUC3 REAGENT LOT NUMBER WAS 812051 WITH AN EXPIRATION DATE OF 30-SEP-2025.

    Description of Event or Problem · 0

    THE INITIAL REPORTER COMPLAINED OF DISCREPANT LOW RESULTS FOR 2 PATIENT SAMPLES TESTED FOR GLUCOSE HK GEN.3 (GLUC3) AND CHOLESTEROL GEN.2 (CHOL2) ON A COBAS 8000 C702 MODULE. PATIENT 1 INITIAL GLUC3 RESULT WAS <0.11 MMOL/L. THE REPEAT RESULT WAS 4.27 MMOL/L. PATIENT 2 INITIAL CHOL2 RESULT WAS 0.81 MMOL/L. THE REPEAT RESULT WAS 3.99 MMOL/L. THE INITIAL GLUC3 RESULT WAS 0.2 MMOL/L. THE REPEAT RESULT WAS 10 MMOL/L.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    928633 COBAS 8000 C702 MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown