BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA 1800 CHEMISTRY SYSTEM

    MDR report key: 7323634 · Received March 8, 2018

    Report

    Report Number
    2432235-2018-00104
    Event Type
    Malfunction
    Date Received
    March 8, 2018
    Date of Event
    February 15, 2018
    Report Date
    March 8, 2018
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JJE
    UDI-DI
    00630414534794
    PMA / PMN Number
    K990346
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS DISPATCHED TO THE SITE TO INSPECT THE ADVIA 1800 CHEMISTRY SYSTEM. THE CSE OBSERVED AN OVERFLOW AT THE REACTION CUVETTE WASH MECHANISM (WUD) AND THE DILUTION CUVETTE WASH MECHANISM (DWUD). THE CSE ADJUSTED THE LARGE WATER PUMP (LWP) DOWN TO 76 PSI, CLEANED ALL WUD AND DWUD NOZZLES, REPLACED SOLENOID VALVES AS NEEDED AND REMOVED A CLOG FROM THE DWUD LINE. THE CSE RAN A CARBON DIOXIDE PRECISION STUDY WITH ACCEPTABLE RESULTS. THE CAUSE OF THE DISCORDANT FALSELY HIGH CARBON DIOXIDE RESULTS IS UNKNOWN. THE SYSTEM IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT FALSELY HIGH CARBON DIOXIDE (CO2_C) PATIENT SAMPLE TEST RESULTS WERE OBTAINED ON AN ADVIA 1800 CHEMISTRY SYSTEM. THE SAME SAMPLES WERE REPEATED ON THE SAME SYSTEM. THE INITIAL RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE REPEAT RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT CARBON DIOXIDE RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    168291 ADVIA 1800 CHEMISTRY SYSTEM ADVIA 1800 CHEMISTRY SYSTEM JJE SIEMENS HEALTHCARE DIAGNOSTICS INC. 00630414534794

    Patients

    Seq Age Sex Outcome Treatment
    1