BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 C 702 MODULE

    MDR report key: 21211068 · Received January 22, 2025

    Report

    Report Number
    1823260-2025-00203
    Event Type
    Malfunction
    Date Received
    January 22, 2025
    Date of Event
    December 29, 2024
    Report Date
    January 22, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K100853
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE GLUC3 REAGENT LOT NUMBER WAS 812051 WITH AN EXPIRATION DATE OF 30-SEP-2025. QC WAS ACCEPTABLE ON THE DAY OF THE EVENT. THE CLIENT IDENTIFIED A YELLOW PIPE AND REQUESTED A SERVICE VISIT FOR VERIFICATION. THE FIELD SERVICE ENGINEER VISITED THE CUSTOMER'S SITE AND FOUND THAT THE REAGENT PROBE WASHES WERE INCONSISTENT. HE ADJUSTED THE REAGENT PROBE WASH STATION VOLUMES. CALIBRATION AND QC WERE PERFORMED WITH SUCCESSFUL RESULTS. THE ROOT CAUSE WAS DUE TO A MAINTENANCE ISSUE (REAGENT PROBE CARRY-OVER). THE SERVICE ACTIONS (ADJUSTING THE REAGENT PROBE WASH STATION VOLUMES) RESOLVED THE ISSUE. NO FURTHER ISSUES WERE REPORTED AFTERWARD.

    Description of Event or Problem · 0

    WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT SERUM/PLASMA SAMPLE TESTED WITH GLUC3 ASSAY ON A COBAS 8000 C702 MODULE WHEN COMPARED TO A DIFFERENT ANALYZER. INITIAL RESULT: 118.1 MG/DL. THE CUSTOMER QUESTIONED THE INITIAL RESULT AS IT DID NOT MATCH THE PATIENT'S HISTORY. NO QUESTIONABLE RESULT WAS REPORTED OUTSIDE THE LABORATORY AND THE SAMPLE WAS REPEATED. REPEAT RESULT: 79.2 MG/DL (TESTED ON ANOTHER ANALYZER). THE REPEAT RESULT WAS CONSIDERED TO BE CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    791775 COBAS 8000 C 702 MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male