BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 C 702 MODULE

    MDR report key: 17697513 · Received September 7, 2023

    Report

    Report Number
    1823260-2023-02913
    Event Type
    Malfunction
    Date Received
    September 7, 2023
    Date of Event
    August 1, 2023
    Report Date
    September 7, 2023
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    UDI-DI
    04015630930845
    PMA / PMN Number
    K100853
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REAGENT LOT NUMBER AND THE EXPIRATION DATE WERE REQUESTED BUT NOT PROVIDED. THE FIELD SERVICE ENGINEER (FSE) CHECKED ALL OF THE LAUNDRY NOZZLES, THE GEAR PUMP HEAD (GPH) PRESSURE, AND THE WASH LEVELS; NO ISSUES WERE NOTED. HE PERFORMED A MECHANISM CHECK AND NOTED THAT TWO OF THE PROBES WERE DRIPPING BACK. HE THEN REPLACED A SOLENOID VALVE. THE CUSTOMER PERFORMED CALIBRATIONS AND QCS WITH SUCCESSFUL RESULTS. THE INVESTIGATION DETERMINED THAT THE EVENT WAS DUE TO A COMPONENT ISSUE. AFTER SERVICE, NO FURTHER ISSUES WERE REPORTED BY THE CUSTOMER. THE INVESTIGATION DETERMINED THE SERVICE ACTIONS RESOLVED THE ISSUE.

    Description of Event or Problem · 0

    THE INITIAL REPORTER RECEIVED QUESTIONABLE LI LITHIUM RESULTS FROM AN UNSPECIFIED NUMBER OF PATIENT SAMPLES TESTED ON THE COBAS 8000 C702 MODULE. THE REPORTER WAS ABLE TO PROVIDE ONE EXAMPLE OF DISCREPANT RESULTS. THE INITIAL RESULT WAS 0.826 MMOL/L. THE FIRST REPEAT RESULT WAS 1.833 MMOL/L. THE SECOND REPEAT RESULT WAS 0.882 MMOL/L.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2120983 COBAS 8000 C 702 MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS 04015630930845

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown